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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The primary objectives of this investigation are to show that the performance of CBL-101 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-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
Participants in this multicenter, randomized study had a screening visit, then were randomized on Day 0 with follow-up visits on Day 7 (±1), Day 28 (± 3) and Day 90 (±10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBL-101 Eye Drops | Experimental | The test article, CBL-101 Eye Drops, is a CE-marked medical device containing 0.15% sodium hyaluronate and polyethylene glycol (PEG) 8000. An oxide (Oxyd®) used as a soft preservative, rapidly turns into oxygen, water and ions on contact with the eye. The formula is presented in 10 mL bottles. |
|
| Vismed® Multi Eye Drops | Active Comparator | The comparator product, Vismed® Multi ophthalmic solution (CE marked), contains 0.18% sodium hyaluronate, is unpreserved and presented in 10 mL bottles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-101 Eye Drops | Device | CBL-101 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 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, 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 7 (Visit 3) | 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 OSFS is the sum score of the 3 subscores (cornea, 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. |
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Inclusion Criteria:
Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent
Subjects must be able to read, understand, and provide written informed consent on the Ethics Committee (EC) approved ICF
Subjects who are able and willing to comply with all treatment and follow-up, study procedures
Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use multidose preservative-free artificial tear (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
Subjects with a 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
Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca :
Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
Subjects with no systemic treatment or who are receiving stable systemic treatment (unchanged for 1 month or longer)
Female subjects who are not of childbearing potential or who have a negative urine pregnancy test result at screening
Exclusion Criteria:
Ocular Exclusion Criteria
Subjects with moderate or severe blepharitis defined by at least moderate (a score of ≥ 2 from a range of 0 to 3) eyelid margin hyperemia or moderate eyelid swelling or both and at least moderate eyelid debris or moderate plugging of meibomian glands or both
Subjects who have severe ocular dryness accompanied by one of the following:
Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start
Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
Treatment Exclusion Criteria
Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
Subjects with 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
Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
Subjects expected to receive ocular therapy during the study
Subjects treated with topical ocular steroidal or non-steroidal antiinflammatory medication within 30 days prior to study start
Subjects expected to receive ocular therapy with immunosuppressants (e.g. cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start
General Exclusion Criteria
Female subjects who are sexually active and who do not fall into 1 of the following categories:
Females who are breastfeeding
Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and, or during the period of study participation
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| Name | Affiliation | Role |
|---|---|---|
| Raphaele Siou Mermet, MD | Laboratoire Chauvin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Nyst private office | Huy | Belgium | ||||
| Pr Mortemousque private office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36269661 | Result | Labetoulle M, Mortemousque B; CBL-101 Study Group. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial. J Ocul Pharmacol Ther. 2022 Nov;38(9):607-616. doi: 10.1089/jop.2022.0048. Epub 2022 Oct 21. |
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87 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 83 participants met inclusion criteria and were randomized either to CBL-101 or Vismed Multi treatment group. Both eyes of each participant were treated with the assigned eye drops.
Participants were recruited from 15 sites in France and 3 sites in Belgium
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| ID | Title | Description |
|---|---|---|
| FG000 | CBL-101 Eye Drops | Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG) |
| 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 with 0.18% sodium hyaluronate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline participants included all 83 randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CBL-101 Eye Drops | Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate, and 0.5% polyethylene glycol (PEG) |
| 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 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, 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. | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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-101 Eye Drops | Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | 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 | Jun 6, 2018 | Jan 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2019 | Jan 24, 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 3 to 6 times per day for 3 months. |
|
| Baseline (Day 0), Visit 3 (Day 7) |
| 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 OSFS is the sum score of the 3 subscores (cornea, 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 5 (Day 90) |
| Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3) | Mean change from baseline (CFB) in the study eye in Corneal 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 Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 3 (Day 7) |
| Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) | Mean change from baseline (CFB) in the study eye in Corneal 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 Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 4 (Day 28) |
| Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Corneal 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 Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome). | Baseline (Day 0), Visit 5 (Day 90) |
| Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3) | 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 3 (Day 7) |
| Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) | 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) |
| Change From Baseline in Nasal Conjunctival Fluorescein Staining Score 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 5 (Day 90) |
| Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3) | 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 3 (Day 7) |
| Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) | 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) |
| Change From Baseline in Temporal Conjunctival Fluorescein Staining Score 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 5 (Day 90) |
| Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) | 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, Visit 4 (Day 28) |
| Change From Baseline in Global Sum Score of Dry Eye Symptoms 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, 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) was 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 7 (Visit 3) | 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated. | Baseline (Day 0), Visit 3 (Day 7) |
| Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) | 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 tenths 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) |
| Change From Baseline in Tear Film Break Up Time (TFBUT) 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated. | Baseline (Day 0), Visit 5 (Day 90) |
| Change From Baseline in Schirmer Test at Day 28 (Visit 4) | Tear fluid secretion was assessed by the unanaesthetized Schirmer's 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 read to the nearest mm from the graduated strip markings. | Baseline (Day 0), Visit 4 (Day 28) |
| Bordeaux |
| 33000 |
| France |
Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes. Vismed® Multi: CE-marked medical device 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 Staining (OSFS) was scored according to a scale (Oxford Scheme) with a total score ranging from a minimum of 0 (best outcome) to a maximum of 15 (worst outcome). The OSFS total score is the sum of 3 subscores (corneal, nasal and temporal regions). Each subscore 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 a minimum of 0 (best outcome) to a maximum of 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Nasal conjunctival fluorescein staining score | The Nasal conjunctival fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome). | Mean | Standard Deviation | units on a scale |
|
| Temporal conjunctival fluorescein staining score | The Temporal conjunctival fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from a minimum of 0 (best outcome) to a maximum of 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 from 0 (absent) to 4 (severe and/or disabling and constant). | Mean | Standard Deviation | units on a scale |
|
| Ocular surface disease-Quality of life (OSD-QoL®): Global question | The Global Question of the OSD-QoL questionnaire was measured on a scale ranging from 0 (worst outcome) to 4 (best outcome). The result was converted to a reporting score ranging from 0 (poor quality of life) to 100 (good quality of life). | Some of the Quality of Life questionnaires could not be analyzed | Mean | Standard Deviation | units on a scale |
|
| Tear film break-up time (TFBUT) | 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 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 the unanaesthetized Schirmer's 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 read to the nearest mm from the graduated strip markings. | Mean | Standard Deviation | millimeters |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CBL-101 Eye Drops | Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes. CBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG) |
| 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 with 0.18% sodium hyaluronate |
|
|
|
| Secondary | Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3) | 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 OSFS is the sum score of the 3 subscores (cornea, 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. | Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 3 (Day 7) |
|
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| 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 OSFS is the sum score of the 3 subscores (cornea, 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. | 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 5 (Day 90) |
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| Secondary | Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3) | Mean change from baseline (CFB) in the study eye in Corneal 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 Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome). | Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 3 (Day 7) |
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| Secondary | Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) | Mean change from baseline (CFB) in the study eye in Corneal 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 Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome). | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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) |
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| Secondary | Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5) | Mean change from baseline (CFB) in the study eye in Corneal 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 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 5 (Day 90) |
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| Secondary | Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3) | 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). | Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 3 (Day 7) |
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| Secondary | Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) | 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). | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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) |
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| Secondary | Change From Baseline in Nasal Conjunctival Fluorescein Staining Score 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 the Day 90 visit. | 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 Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3) | 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). | Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 0), Visit 3 (Day 7) |
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| Secondary | Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) | 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). | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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) |
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| Secondary | Change From Baseline in Temporal Conjunctival Fluorescein Staining Score 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, one in each group withdrew before the Day 90 visit. | 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 Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) | 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). | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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, Visit 4 (Day 28) |
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| Secondary | Change From Baseline in Global Sum Score of Dry Eye Symptoms 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, Visit 5 (Day 90) |
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| 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) was 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 Global question on 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 7 (Visit 3) | 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated. | Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit. | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 0), Visit 3 (Day 7) |
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| Secondary | Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) | 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated. | Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of 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 | seconds | Baseline (Day 0), Visit 4 (Day 28) |
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| Secondary | Change From Baseline in Tear Film Break Up Time (TFBUT) 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 tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated. | Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit. | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 0), 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 unanaesthetized Schirmer's 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 read to the nearest mm from the graduated strip markings. | Analysis population included participants in the per-protocol population with evaluable Schirmer test on Day 0 and Day 28. | Posted | Least Squares Mean | Standard Error | mm / 5 min | Baseline (Day 0), Visit 4 (Day 28) |
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| 0 |
| 45 |
| 0 |
| 45 |
| 2 |
| 45 |
| 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 with 0.18% sodium hyaluronate | 0 | 38 | 0 | 38 | 1 | 38 |
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.
| Handicap and work difficulties |
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| Giving up makeup |
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| Acknowledgement of the disease |
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| Acceptance of the disease |
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| Fear for the future |
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| Emotional well-being |
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| Global Question |
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