A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Laboratoire Chauvin
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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 :
- •Tear break-up time of 10 sec (mean of 3 measurements) at both screening visit and inclusion visit
- •Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme
- •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:
Exclusion Criteria
- •Severe blepharitis
- •Severe ocular dryness accompanied by 1 of the following:
- •Lid abnormality
- •Corneal disease
- •Ocular surface metaplasia
- •Filamentary keratitis
- •Corneal neovascularization
- •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
Outcomes
Primary Outcomes
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
Time Frame: Baseline (Day 0), Visit 4 (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.
Secondary Outcomes
- Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)(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)(Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90))
- Change From Baseline in Schirmer Test at Day 28 (Visit 4)(Baseline (Day 0), Visit 4 (Day 28))
- Frequency of Eye Drop Instillation(From Day 0 to Day 90, an average of 3 months)
- Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)(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)(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)(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)(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)(Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90))