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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-15-05-013553 | Other Identifier | EudaMed |
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The objective of this study was to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular discomfort following refractive surgery.
Primary objectives:
Secondary objectives:
All parameters were evaluated at V1 (Day 1 - Baseline), V2 (Day 15±2) and V3 (Day 22±2/ETV).
This study was a 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular discomfort following refractive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubricin 20µg/ml | Experimental | Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. |
|
| Lubricin 50µg/ml | Experimental | Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. |
|
| Sodium hyaluronate |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubricin 20µg/ml | Device | Lubricin 20µg/ml eye drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophtalmic assessment at each scheduled visit. Specific ocular symptoms measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as extreme limits of the parameter. | Day 1 (baseline = Visit 1) at pre-dose, 15, 30 min post-dose; Day 15±2 (= Visit 2) at pre-dose, 15, 30 min post-dose; Day 22±2 (= Visit 3) |
| Treatment-emergent Adverse Events (TEAEs) Assessed Throughout the Study | TEAEs included all AEs occurring or worsening after the first dose of IMD. These comprise AEs during the treatment and follow-up period. For TEAE, the number of events was provided. At each visit (Visit 1 which took place at Day 1; Visit 2 which took place at day 15 ± 2; Visit 3, i.e. final visi FU, at Day 22 ± 2/ETV), patients could spontaneously report any physical or medical occurrence and the investigator or designee inquired about the occurrence of TEAEs by asking specific questions. Any untoward (unfavorable & unintended) change in subject's medical conditions was to be reported as an AE. Changes in any protocol-specific ocular or systemic parameter evaluated during the study were to be reviewed by the investigator. In addition, each patient's response to any questionnaire was to be reviewed by the investigator. Any untoward (unfavorable and unintended) change in a protocol-specific parameter or questionnaire response clinically relevant was to be reported as an AE. | From baseline (Day 1 - pre-dose) to day 22±2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) | The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. It was performed after instillation of sodium fluoresce into the inferior conjunctival cul-de-sac of each eye with the aid of a slit lamp at 10X magnification using cobalt blue illumination. The Oxford scale grading divides corneal staining into six groups for each panel, based on the severity [from 0 (absent) to 5 (severe)]. The corneal staining is represented by punctate dots on a series of panels (panel A=grade 0 to panel >E=grade 5). Staining ranges from 0-5 for each panel, and 0-15 for the total exposed inter-palpebral conjunctiva and cornea. The examiner selected the appropriate grade that best represented the state of corneal staining intuitional. The higher the grade, the worst is the overall outcome value. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007);
Best corrected distance visual acuity (BCDVA) score of < 0.1 decimal units in either eye at the time of study enrolment;
Evidence of an active ocular infection in either eye;
History or presence of ocular surface disorders other than ocular discomfort in either eye;
Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period;
Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment;
History of any ocular surgery (excluding laser or refractive surgical procedures) in either eye within 30 days before study enrolment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period;
Known hypersensitivity to one of the components of the study or procedural medications;
Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit;
History of drug, medication or alcohol abuse or addiction;
Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Mantelli, MD-PhD | Dompé Farmaceutici S.p.A | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento "Organi di senso" Università La Sapienza- Policlinico Umberto I | Rome | 00161 | Italy |
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Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 μg/mL eye drops solution or Lubricin 50 μg/mL eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution were enrolled, randomised and treated. The enrolled and safety analysis sets included all 30 enrolled and treated subjects, while the full analysis set (FAS) included 29 subjects and excluded one of the 2 discontinued subjects due to major protocol deviations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubricin 20µg/ml | Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops |
| FG001 | Lubricin 50µg/ml | Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops |
| FG002 | Sodium Hyaluronate | Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Demographics are based on the Enrolled set (n=30)
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubricin 20µg/ml | Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophtalmic assessment at each scheduled visit. Specific ocular symptoms measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as extreme limits of the parameter. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). This analysis set was used for the efficacy analysis. Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | mm | Day 1 (baseline = Visit 1) at pre-dose, 15, 30 min post-dose; Day 15±2 (= Visit 2) at pre-dose, 15, 30 min post-dose; Day 22±2 (= Visit 3) | eyes | eyes |
The specific period of time over which adverse events data were collected was from Day 1 (Visit 1) to Day 22±2 (Final Visit - Follow up) or Early Termination Visit (ETV).
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medical product and which did non necessarily have a causal relationship with this treatment. AE = any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
No TEAE occurred during the study, neither serious, nor non serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubricin 20µg/ml (SAF) | Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development & Operations | Dompé Farmaceutici SpA | +39 02 583831 | clinical.trials@dompe.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2016 | Dec 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Dec 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C537560 | Jacobs syndrome |
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The packaging used for the comparator in the present investigation aimed at ensuring a complete masking of the test IMD.
Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. |
|
| Lubricin 50µg/ml |
| Device |
Lubricin 50µg/ml eye drops |
|
| Sodium hyaluronate 0.18% | Device | Sodium hyaluronate (HA) 0.18% eye drops |
|
|
| Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in Schirmer-I Test (Without Anaesthesia) | The Schirmer test Type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops. The rounded bent end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | TFBUT was measured by determining the time to tear break-up. The TFBUT test was performed after instillation of 5 μl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner monitored the integrity of the tear film, noting the time it took to form lacunae (clear spaces in the tear film) from the time that the eye was opened after the last blink. This measurement was performed within 10 seconds maximum. The TFBUT was measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differed by more than 2 seconds, a third reading was taken. The TFBUT value was the average of the 2 or 3 measurements. Generally, a TFBUT value of 10-35 seconds was considered normal. A value of less than 10 seconds was usually suspicious and may indicate tear film instability. The higher the value, the better the outcome. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Best corrected visual acuity (BCDVA) was determined by careful refraction according to the standard protocol for refraction. Chart 1 was used for testing the VA of the right eye; Chart 2 for the left eye; and Chart R for refraction only. Retroilluminated standard Early Treatment of Diabetic Retinopathy Study (ETDRS) charts were used. They had 5 Sloan letters on each line of equal difficulty, and there was a geometric progression in letter size from line to line. VAS awarded one point for every letter correctly guessed. A distance of 4 meters was required between the subject's eyes and the VA chart. When a subject cannot read at least 20 letters on the chart at 4 meters, the subject was tested at 1 meter. If 20 or more letters were read at 4 meters, the VAS for that eye was recorded as the number of letters correct at 4 meters plus 30. Otherwise, the VAS was the number of letters read correctly at 1 meter plus the number read at 4 meters. The higher the score the better the outcome. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores | The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye frequency and severity by using a 100 mm VAS. The subject symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assess both severity and frequency of symptoms. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimeters from the left hand end of the line to the point that the subject marked. The SANDE scores was then evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in Slit Lamp Examination (SLE) Values | The Slit Lamp Examination was used to examine the structures of the eye (eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber) according to different scales: Eyelid - Meibomian glands (from 0-none to 3-severe), Eyelid - Erythema (from 0-none to 4-very severe), Eyelid - Oedema (from 0-none to 4-very severe), Lashes (0-normal 1-abnormal), Conjunctiva - Erythema (from 0-none to 3-severe), Conjunctiva - Oedema (from 0-none to 4-very severe), Lens (to 0-no opacification to 3-severe opacification), Iris (0-normal 1-abnormal), Anterior chamber inflammation (from 0-none to 3-severe), Cornea transparency (from 0-completely transparent to 4-complete cornea opacity), Cornea neovascularization (0-absence of vascularization to 4- neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in IOP (Intraocular Pressure) | The IOP (intraocular pressure) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and ease with which it leaved the eye. IOP was performed using Goldmann applanation tonometry after the instillation of a topical anaesthetic. The Goldmann applanation tonometer measured the force necessary to flatten a corneal area of 3.06 mm diameter. At this diameter, the resistance of the cornea to flattening was counterbalanced by the capillary attraction of the tear film meniscus for the tonometer head. The IOP (in mm Hg) equals the flattening force (in grams) multiplied by 10. IOP was measured in both eyes after completion of all SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mmHg. High ocular pressure was greater than 21 mmHg. | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
| Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry | The Cochet-Bonnet aesthesiometer contained a thin, retractable, nylon monofilament that extended up to 6 cm in length. Variable pressure could be applied to the cornea by adjusting the monofilament length. The monofilament length ranged from 6 to 0.5 cm. As the monofilament length was decreased the pressure increased from 11 mm/gm to 200 mm/gm. Corneal sensation was measured in the affected eye(s) in the central area of the cornea using a Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The length of the filament in cm at which the patient corneal sensation was observed for the tested area of the cornea was reported. With decreasing length of monofilament, the corneal touch threshold increased and the corneal sensitivity decreased. Therefore, decreasing the length of monofilament was proportional to decreased corneal sensitivity. | From baseline (Day 1 pre-dose) to Day 15±2 and Day 22±2 |
| BG001 | Lubricin 50µg/ml | Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops |
| BG002 | Sodium Hyaluronate | Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Lubricin 20µg/ml (FAS) | Lubricin 20µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 20µg/ml: Lubricin 20µg/ml eye drops |
| OG001 | Lubricin 50µg/ml (FAS) | Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops |
| OG002 | Sodium Hyaluronate (FAS) | Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops |
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| Primary | Treatment-emergent Adverse Events (TEAEs) Assessed Throughout the Study | TEAEs included all AEs occurring or worsening after the first dose of IMD. These comprise AEs during the treatment and follow-up period. For TEAE, the number of events was provided. At each visit (Visit 1 which took place at Day 1; Visit 2 which took place at day 15 ± 2; Visit 3, i.e. final visi FU, at Day 22 ± 2/ETV), patients could spontaneously report any physical or medical occurrence and the investigator or designee inquired about the occurrence of TEAEs by asking specific questions. Any untoward (unfavorable & unintended) change in subject's medical conditions was to be reported as an AE. Changes in any protocol-specific ocular or systemic parameter evaluated during the study were to be reviewed by the investigator. In addition, each patient's response to any questionnaire was to be reviewed by the investigator. Any untoward (unfavorable and unintended) change in a protocol-specific parameter or questionnaire response clinically relevant was to be reported as an AE. | The Safety population (SAF) included all patients who received and used at least once the IMDs (Lubricin or Vismed ®). | Posted | Number | events | From baseline (Day 1 - pre-dose) to day 22±2 |
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| Secondary | Change From Baseline in Ocular Surface Vital Staining With Fluorescein (Oxford Scale) | The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. It was performed after instillation of sodium fluoresce into the inferior conjunctival cul-de-sac of each eye with the aid of a slit lamp at 10X magnification using cobalt blue illumination. The Oxford scale grading divides corneal staining into six groups for each panel, based on the severity [from 0 (absent) to 5 (severe)]. The corneal staining is represented by punctate dots on a series of panels (panel A=grade 0 to panel >E=grade 5). Staining ranges from 0-5 for each panel, and 0-15 for the total exposed inter-palpebral conjunctiva and cornea. The examiner selected the appropriate grade that best represented the state of corneal staining intuitional. The higher the grade, the worst is the overall outcome value. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | score on a scale | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in Schirmer-I Test (Without Anaesthesia) | The Schirmer test Type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops. The rounded bent end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | mm/5min | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | TFBUT was measured by determining the time to tear break-up. The TFBUT test was performed after instillation of 5 μl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner monitored the integrity of the tear film, noting the time it took to form lacunae (clear spaces in the tear film) from the time that the eye was opened after the last blink. This measurement was performed within 10 seconds maximum. The TFBUT was measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differed by more than 2 seconds, a third reading was taken. The TFBUT value was the average of the 2 or 3 measurements. Generally, a TFBUT value of 10-35 seconds was considered normal. A value of less than 10 seconds was usually suspicious and may indicate tear film instability. The higher the value, the better the outcome. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | seconds | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Best corrected visual acuity (BCDVA) was determined by careful refraction according to the standard protocol for refraction. Chart 1 was used for testing the VA of the right eye; Chart 2 for the left eye; and Chart R for refraction only. Retroilluminated standard Early Treatment of Diabetic Retinopathy Study (ETDRS) charts were used. They had 5 Sloan letters on each line of equal difficulty, and there was a geometric progression in letter size from line to line. VAS awarded one point for every letter correctly guessed. A distance of 4 meters was required between the subject's eyes and the VA chart. When a subject cannot read at least 20 letters on the chart at 4 meters, the subject was tested at 1 meter. If 20 or more letters were read at 4 meters, the VAS for that eye was recorded as the number of letters correct at 4 meters plus 30. Otherwise, the VAS was the number of letters read correctly at 1 meter plus the number read at 4 meters. The higher the score the better the outcome. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | score on a scale | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) Questionnaire Scores | The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye frequency and severity by using a 100 mm VAS. The subject symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assess both severity and frequency of symptoms. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimeters from the left hand end of the line to the point that the subject marked. The SANDE scores was then evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). | Posted | Mean | Standard Deviation | mm | Day 15±2 (Visit 2); Day 22±2 (Visit 3) |
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| Secondary | Change From Baseline in Slit Lamp Examination (SLE) Values | The Slit Lamp Examination was used to examine the structures of the eye (eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber) according to different scales: Eyelid - Meibomian glands (from 0-none to 3-severe), Eyelid - Erythema (from 0-none to 4-very severe), Eyelid - Oedema (from 0-none to 4-very severe), Lashes (0-normal 1-abnormal), Conjunctiva - Erythema (from 0-none to 3-severe), Conjunctiva - Oedema (from 0-none to 4-very severe), Lens (to 0-no opacification to 3-severe opacification), Iris (0-normal 1-abnormal), Anterior chamber inflammation (from 0-none to 3-severe), Cornea transparency (from 0-completely transparent to 4-complete cornea opacity), Cornea neovascularization (0-absence of vascularization to 4- neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | score on a scale | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in IOP (Intraocular Pressure) | The IOP (intraocular pressure) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and ease with which it leaved the eye. IOP was performed using Goldmann applanation tonometry after the instillation of a topical anaesthetic. The Goldmann applanation tonometer measured the force necessary to flatten a corneal area of 3.06 mm diameter. At this diameter, the resistance of the cornea to flattening was counterbalanced by the capillary attraction of the tear film meniscus for the tonometer head. The IOP (in mm Hg) equals the flattening force (in grams) multiplied by 10. IOP was measured in both eyes after completion of all SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mmHg. High ocular pressure was greater than 21 mmHg. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). Please note that for participants, study eye and non-study eye values were assessed and reported. | Posted | Mean | Standard Deviation | mmHg | Day 15±2 (Visit 2); Day 22±2 (Visit 3) | eyes | eyes |
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| Secondary | Change From Baseline in Corneal Sensitivity by Cochet-Bonnet Aesthesiometry | The Cochet-Bonnet aesthesiometer contained a thin, retractable, nylon monofilament that extended up to 6 cm in length. Variable pressure could be applied to the cornea by adjusting the monofilament length. The monofilament length ranged from 6 to 0.5 cm. As the monofilament length was decreased the pressure increased from 11 mm/gm to 200 mm/gm. Corneal sensation was measured in the affected eye(s) in the central area of the cornea using a Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The length of the filament in cm at which the patient corneal sensation was observed for the tested area of the cornea was reported. With decreasing length of monofilament, the corneal touch threshold increased and the corneal sensitivity decreased. Therefore, decreasing the length of monofilament was proportional to decreased corneal sensitivity. | The Full Analysis Set (FAS) population included all randomised patients, who received and used at least once the investigational device (Lubricin or Vismed®). | Posted | Mean | Standard Deviation | cm | From baseline (Day 1 pre-dose) to Day 15±2 and Day 22±2 | eyes | eyes |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Lubricin 50µg/ml (SAF) | Lubricin 50µg/ml eye drops solution Test investigational device was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Lubricin 50µg/ml: Lubricin 50µg/ml eye drops | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Sodium Hyaluronate 0.18% (SAF) | Vismed® 0.18% Sodium hyaluronate (HA) eye drops Comparator was instilled t.i.d. (three times a day) approximately every 6 h, from day 1 to day 15±2. All the patients instilled their assigned IMD into both eyes, unless only one eye met the eligibility criteria. If just one eye met the eligibility criteria, that was identified as the "Study/Primary eye". If both eyes met the eligibility criteria, the worst one (highest VAS average score) was chosen as "Study/Primary eye". In the event that the mean VAS score was equal in both eyes, right eye was to be chosen as "Study/Primary eye". The investigator instilled the morning study dose on Day 1 then the patients self-instilled the drops at home/site, as applicable. After the end of the treatment period, all the subjects could use any ocular topical treatment allowed, including other artificial tears/lubricants as prescribed by the treating physician, from day 15±2 to day 21±2. Sodium hyaluronate 0.18%: Sodium hyaluronate (HA) 0.18% eye drops | 0 | 10 | 0 | 10 | 0 | 10 |
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| Study eye - Day 22±2 |
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| Non Study eye - Day 15±2 |
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| Non Study eye - Day 22±2 |
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Study eye - Day 15±2 pre-dose |
| Student t-test pooled |
Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining |
| 0.2854 |
| Mean Difference (Final Values) |
| 0.3 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.7 |
| Superiority |
| Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose | Student t-test pooled | Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining - | 0.6525 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.6 | 0.4 | Superiority |
| Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining - | 0.8843 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.4 | 0.5 | Superiority |
| Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining | 0.0806 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.6 | 0.0 | Superiority |
| Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining | 0.0628 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.7 | 0.0 | Superiority |
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| Study eye - Day 22±2 |
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| Non Study eye - Day 15±2 |
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| Non Study eye - Day 22±2 |
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Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose
| Student t-test pooled |
Pooled method for estimating common variance was used |
| 0.5413 |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.6 |
| Superiority |
| Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.4607 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.8 | 0.4 | Superiority |
| Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.1248 | Mean Difference (Final Values) | 0.6 | 2-Sided | 95 | -0.2 | 1.4 | Superiority |
| Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.0624 | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | 0.0 | 1.1 | Superiority |
| Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.7927 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -1.0 | 0.8 | Superiority |
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| Study eye - Day 22±2 |
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| Non Study eye - Day 15±2 |
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| Non Study eye - Day 22±2 |
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Study eye - Day 15±2 pre-dose
| Student t-test pooled |
Pooled method for estimating common variance was used |
| 0.7386 |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.9 |
| Superiority |
| Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.7498 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.6 | 0.8 | Superiority |
| Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.3229 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.1 | 0.4 | Superiority |
| Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.5700 | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -0.5 | 0.9 | Superiority |
| Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.1197 | Mean Difference (Final Values) | 0.6 | 2-Sided | 95 | -0.2 | 1.3 | Superiority |
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| Study eye - Day 22±2 |
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| Non Study eye - Day 15±2 |
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| Non Study eye - day 22±2 |
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| Student t-test pooled |
| 0.8159 |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.5 |
| 0.7 |
| Superiority |
| Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose | Student t-test pooled | 0.6525 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.4 | 0.6 | Superiority |
| Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | 0.3340 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.0 | 0.4 | Superiority |
| Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | 0.9749 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.7 | 0.7 | Superiority |
| Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | 0.1984 | Mean Difference (Final Values) | 0.3 | 2-Sided | 95 | -0.2 | 0.9 | Superiority |
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| Severity of Symptoms - Day 15±2 |
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| Severity of Symptoms - Day 22±2 |
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Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose |
| Student t-test pooled |
Pooled method for estimating common variance was used |
| 0.1443 |
| Mean Difference (Final Values) |
| -6.9 |
| 2-Sided |
| 95 |
| -16.5 |
| 2.6 |
| Superiority |
| Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.0751 | Mean Difference (Final Values) | -9.9 | 2-Sided | 95 | -20.9 | 1.1 | Superiority |
| Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.5015 | Mean Difference (Final Values) | 3.8 | 2-Sided | 95 | -7.9 | 15.5 | Superiority |
| Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.3217 | Mean Difference (Final Values) | -4.1 | 2-Sided | 95 | -12.5 | 4.4 | Superiority |
| Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.1026 | Mean Difference (Final Values) | -7.9 | 2-Sided | 95 | -17.5 | 1.8 | Superiority |
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| Eyelid - Meibomian glands ( Non Study eye) - Day15±2 |
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| Eyelid - Meibomian glands (Study eye) - Day 22±2 |
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| Eyelid - Meibomian glands (Non Study eye) - Day 22±2 |
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| Eyelid erythema (Study eye) - Day 15±2 |
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| Eyelid erythema (Non Study eye) - Day 15±2 |
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| Eyelid erythema (Study eye) - Day 22±2 |
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| Eyelid erythema (Non Study eye) - Day 22±2 |
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| Eyelid Oedema (Study eye) - Day 15±2 |
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| Eyelid Oedema (Non Study eye) - Day 15±2 |
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| Eyelid Oedema (Study eye) - Day 22±2 |
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| Eyelid Oedema (Non Study eye) - Day 22±2 |
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| Lashes (Study eye) - Day 15±2 |
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| Lashes (Non Study eye) - Day 15±2 |
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| Lashes (Study eye) - Day 22±2 |
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| Lashes (Non Study eye) - Day 22±2 |
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| Conjunctiva - erythema (Study eye) - Day 15±2 |
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| Conjunctiva - erythema (Non Study eye) - Day 15±2 |
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| Conjunctiva - erythema (Study eye) - Day 22±2 |
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| Conjunctiva - erythema (Non Study eye) - Day 22±2 |
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| Conjunctiva - oedema (Study eye) - Day 15±2 |
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| Conjunctiva - oedema (Non Study eye) - Day 15±2 |
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| Conjunctiva - oedema (Study eye) - Day 22±2 |
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| Conjunctiva - oedema (Non Study eye) - Day 22±2 |
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| Lens (Study eye) - Day 15±2 |
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| Lens (Non Study eye) - Day 15±2 |
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| Lens (Study eye) - Day 22±2 |
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| Lens (Non Study eye) - Day 22±2 |
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| Iris (Study eye) - Day 15±2 |
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| Iris (Non Study eye) - Day 15±2 |
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| Iris (Study eye) - Day 22±2 |
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| Iris (Non Study eye) - Day 22±2 |
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| Anterior chamber inflammation (Study eye) - Day 15±2 |
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| Anterior chamber inflammation (Non Study eye) - Day 15±2 |
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| Anterior chamber inflammation (Study eye) - Day 22±2 |
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| Anterior chamber inflammation (Non Study eye) - Day 22±2 |
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| Cornea transparency (Study eye) - Day 15±2 |
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| Cornea transparency (Non Study eye) - Day 15±2 |
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| Cornea transparency (Study eye) - Day 22±2 |
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| Cornea transparency (Non Study eye) - Day 22±2 |
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| Cornea neovascularization (Study eye) - Day 15±2 |
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| Cornea neovascularization (Non Study eye) - Day 15±2 |
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| Cornea neovascularization (Study eye) - Day 22±2 |
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| Cornea neovascularization (Non Study eye) - Day 22±2 |
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| Wilcoxon (Mann-Whitney) |
| 1.000 |
| Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.4101 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.5267 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.2633 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.6552 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.1262 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.2094 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 0.0377 | Hodges Lehmann estimation | -1.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
| Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose | Wilcoxon (Mann-Whitney) | 1.000 | Superiority |
|
| Non study eye - Day 15±2 |
|
|
| Study eye - Day 22±2 |
|
|
| Non Study eye - Day 22±2 |
|
|
Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose
| Student t-test pooled |
Pooled method for estimating common variance was used |
| 0.4606 |
| Mean Difference (Final Values) |
| -0.6 |
| 2-Sided |
| 95 |
| -2.2 |
| 1.0 |
| Superiority |
| Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.2319 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -3.0 | 0.8 | Superiority |
| Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.6018 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -2.3 | 1.4 | Superiority |
| Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.4857 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -2.2 | 1.1 | Superiority |
| Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.9015 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -2.0 | 1.8 | Superiority |
|
| Non Study eye - Day 15±2 |
|
|
| Study eye - Day 22±2 |
|
|
| Non Study eye - Day 22±2 |
|
|
Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose |
| Student t-test pooled |
Pooled method for estimating common variance was used |
| 0.3574 |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.1 |
| 0.3 |
| Superiority |
| Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 00 | P-value is NA due to the measured values of corneal sensitivity equal to zero. | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority |
| Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 00 | P-value is NA due to the measured values of corneal sensitivity equal to zero. | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority |
| Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.1 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.1 | 0.3 | Superiority |
| Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose | Student t-test pooled | Pooled method for estimating common variance was used | 0.1 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.1 | 0.3 | Superiority |