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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01099-44 | Other Identifier | ANSM Registry Office RCB - France |
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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
This was a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects were planned to be randomized in a 1:1 ratio.
The primary performance endpoint was the mean change from baseline (CFB) in the study eye at Day 28 in the Ocular surface fluorescein staining score as assessed by the Oxford Scheme.
Following a screening visit (Visit 1) and a 2-week washout with povidone 2% artificial tear (ART), participants were randomized on Day 0 (Visit 2) with follow-up visits on Day 28 ±3 (Visit 4) and Day 90 ±10 (Visit 5). A telephone assessment took place on Day 7 ±1 ('Visit 3') for safety and compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBL-102 eye drops | Experimental | CE marked medical device, tear substitute containing 0.24% hyaluronic acid salt, carbomer and medium chain triglycerides, presented in 10 mL bottles |
|
| Vismed Multi eye drops | Active Comparator | CE marked medical device, tear substitute containing 0.18% sodium hyaluronate, presented in 10 mL bottles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-102 eye drops | Device | CBL-102 eye drops, 3 to 6 times per day for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28 | Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, nasal and temporal regions). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye. | Baseline (Day 0), Visit 4 (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye. |
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Inclusion Criteria:
Age of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form
Ability and willingness to comply with all treatment and follow-up and study procedures
Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (Aqualarm® U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization
Symptom score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light
At least 1 eye with the following signs of keratoconjunctivitis sicca :
A decimal visual acuity with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
No systemic treatment or who had received stable systemic treatment (unchanged for 1 month or longer)
Female subjects had to be into 1 of the following categories:
Female of childbearing potential needed a negative urine pregnancy test result at screening
Exclusion Criteria:
Severe blepharitis
Severe ocular dryness accompanied by 1 of the following:
Use of contact lenses at inclusion or within 90 days prior to study start
History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start
History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
History of ocular allergic disease or ocular herpes within 1 year prior to study start
History of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
Known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
Initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study
Ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
Expected use of ocular therapy during the study
Use of topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start
Expected use of ocular therapy with immunosuppressants during the study or use of ocular immunosuppressants within 90 days prior to study start
Use of occlusion therapy with non-resorbable lacrimal or punctum plugs within 90 days prior to study start or use of resorbable plugs
Use or planned use of therapy such as LipiFlow® or BlephEx®
Breastfeeding females
Participation in any drug or device clinical investigation within 30 days prior to entry into study and/or during the period of study participation
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| Name | Affiliation | Role |
|---|---|---|
| Marc Labetoulle, M.D Ph.D | Hôpital Kremlin-Bicêtre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Kremlin-Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
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92 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 87 participants met inclusion criteria and were randomized either to CBL-202 or Vismed Multi treatment group. Both eyes of each participant were treated with assigned eye drops.
Participants were recruited from 16 sites in France
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| ID | Title | Description |
|---|---|---|
| FG000 | CBL-102 Eye Drops | Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides |
| FG001 | Vismed® Multi Eye Drops | Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data were only collected for Intention-to-treat population. Intention-to-treat-population: all participants with treatment and a post-baseline assessment Each Baseline Participant contributed one study eye.
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| ID | Title | Description |
|---|---|---|
| BG000 | CBL-102 Eye Drops | Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides |
| BG001 | Vismed® Multi Eye Drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28 | Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, nasal and temporal regions). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye. | Per-protocol population: all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint) | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 4 (Day 28) |
Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days).
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded
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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 | CBL-102 Eye Drops | Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides Safety population |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | 76-year-woman was diagnosed with breast cancer after Day 28 visit. Study product stopped, no final visit. Remission of breast cancer after surgery & radiotherapy. Event was assessed as unrelated to study product or study procedure by investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA | Systematic Assessment |
The participants were not masked to treatment as the compared products were provided in their original bottles to maintain their aseptic conditions but all the bottles were relabelled with no trade name. Labels and outer packaging were identical except for randomization number. Participants received sealed boxes and returned sealed boxes with instructions to keep the investigator masked.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Global Clinical Operations | Bausch + Lomb | +49 30 330 93 | 318 | natasa.orlic-pleyer@bausch.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 | Jul 25, 2017 | Oct 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2021 | Oct 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Vismed Multi eye drops |
| Device |
Vismed Multi eye drops, 3 to 6 times per day for 3 months |
|
| Baseline (Day 0), Visit 5 (Day 90) |
| Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal Region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
| Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
| Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal Conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90) |
| Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5) | The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant). | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
| Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) | The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life. | Baseline (Day 0), Visit 5 (Day 90) |
| Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5) | The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenth of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated. | Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90) |
| Change From Baseline in Schirmer Test at Day 28 (Visit 4) | Tear fluid secretion was assessed by the un-anaesthetized Schirmer test in the study eye with graduated strips in millimeters. Schirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion ready to the nearest mm from the graduated strip margins. | Baseline (Day 0), Visit 4 (Day 28) |
| Frequency of Eye Drop Instillation | Mean daily frequency of investigational eye drop instillations as reported in participant's diary | From Day 0 to Day 90, an average of 3 months |
Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular surface fluorescein staining | The Ocular Surface Fluorescein Score (OSFS) was scored according to scale (Oxford Scheme) with total score ranging from a minimum of 0 (best outcome) to a maximum of 15 (worst outcome). The total OSFS total score is the sum of 3 sub-scores (corneal, nasal and temporal regions). Each sub-score ranges from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Corneal fluorescein staining score | The Corneal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Nasal conjunctival fluorescein staining score | The Nasal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Temporal conjunctival fluorescein staining score | The Temporal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Global dry eye symptoms score | The Global dry eye symptom score was the sum score (scale 0-28) of dry eye symptoms assessing 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light), each graded individually from 0 (absence) to 4 (severe and/or disabling and constant). | Mean | Standard Deviation | units on a scale |
|
| Ocular surface disease-Quality of life (OSD-QoL®) | The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0-100, with a higher score reflecting a better quality of life. | Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data. Giving up makeup dimension was only completed by women. | Mean | Standard Deviation | units on a scale |
|
| Tear film break-up time (TFBUT) | The Tear Film Break Up Time (TFBUT) is assessed after fluorescein instillation and is the time measured between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated. | Mean | Standard Deviation | seconds |
|
| Schirmer's test | Tear fluid secretion was assessed by un-anaesthetised Schirmer's test in the study eye with graduated strips in millimetres. Schirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion was read to the nearest mm from the graduated strip margin. | Mean | Standard Deviation | millimeters |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CBL-102 Eye Drops | Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides |
| OG001 | Vismed® Multi Eye Drops | Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate |
|
|
|
| Secondary | Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye. | Two participants of per-protocol population, one in each group withdrew before Day 90 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 5 (Day 90) |
|
|
|
|
| Secondary | Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal Region is graded separately from 0 (best outcome) to 5 (worst outcome). | Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
|
|
|
|
| Secondary | Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome). | Two participants of the per-protocol population, one in each group withdrew before Day 90 (Visit 5) | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
|
|
|
|
| Secondary | Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal Conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome). | Two participants of the per-protocol population, on in each group withdrew before Day 90 (Visit 5) | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90) |
|
|
|
|
| Secondary | Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5) | The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant). | Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90) |
|
|
|
|
| Secondary | Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5) | The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life. | Analysis population included participants in the per-protocol population with evaluable Questionnaire dimension or Global question on both Day 0 and Day 90. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 5 (Day 90) |
|
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|
|
| Secondary | Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5) | The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenth of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated. | Per-protocol population. Two participants of the per-protocol population, one in each group, withdrew before the Day 90 (Visit 5). | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90) |
|
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| Secondary | Change From Baseline in Schirmer Test at Day 28 (Visit 4) | Tear fluid secretion was assessed by the un-anaesthetized Schirmer test in the study eye with graduated strips in millimeters. Schirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion ready to the nearest mm from the graduated strip margins. | Per -protocol population | Posted | Least Squares Mean | Standard Error | mm/5 min | Baseline (Day 0), Visit 4 (Day 28) |
|
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|
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| Secondary | Frequency of Eye Drop Instillation | Mean daily frequency of investigational eye drop instillations as reported in participant's diary | Two participants of the per-protocol population, one in each group withdrew before the Day 90 (Visit 5). | Posted | Mean | Standard Deviation | drops per day | From Day 0 to Day 90, an average of 3 months |
|
|
|
|
| 0 |
| 47 |
| 1 |
| 47 |
| 0 |
| 47 |
| EG001 | Vismed® Multi Eye Drops | Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate Safety population | 0 | 39 | 0 | 39 | 2 | 39 |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
Sponsor have at least 60 days to review any publication or presentation. The first release of results will involve all sites in this multicenter study.
| CFB in Corneal Fluorescein Score at Day 90 (Visit 5) |
|
|
| Change from Baseline in Nasal Conjunctival Fluorescein Staining Score at day 90 (Visit 5) |
|
|
| Change From BAseline in Temporal Conjunctival Staining Score at Day 90 (Visit 5) |
|
|
| Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5) |
|
|
| ANCOVA |
Adjustment to baseline |
| 0.0010 |
Significance level 0.05 |
| Superiority |
| Difficulties with work and handicap |
|
|
| Giving up makeup |
|
|
| acknowledgement of the disease |
|
|
| acceptance of the disease |
|
|
| Fear for the future |
|
|
| Emotional well-beig |
|
|
| Global Question |
|
|
Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:
Difficulties with work and handicap
| ANCOVA |
Adjustment for baseline |
| 0.0015 |
Significance level of 0.05 |
| Superiority |
| Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension: Giving up makeup | ANCOVA | Adjustment for baseline | 0.2024 | Significance level 0.05 | Superiority |
| Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension: Acknowledgement of the Disease | ANCOVA | Adjustment for baseline | 0.0421 | Significance level 0.05 | Superiority |
| Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension: Acceptance of the disease | ANCOVA | Adjustment for baseline | 0.3945 | Significance level 0.05 | Superiority |
| Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension: Fear for the Future | ANCOVA | Adjustment for baseline | 0.0536 | Significance level of 0.05 | Superiority |
| Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension: Emotional well-being | ANCOVA | Adjustment for baseline | 0.1998 | Significance level of 0.05 | Superiority |
| Ocular Surface Disease-Quality of Life (OSD-QoL®) questions: Global Question | ANCOVA | Adjustment for baseline | 0.0306 | Significance level of 0.05 | Superiority |
| Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5) |
|
|