Status:
COMPLETED
A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Lead Sponsor:
Laboratoire Chauvin
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 keratoconjunc...
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 endpoin...
Eligibility Criteria
Inclusion
- 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:
- Post-menopausal
- Surgically sterile
- Using birth control method throughout the duration of the study
- Female of childbearing potential needed a negative urine pregnancy test result at screening
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03368404
Start Date
November 9 2017
End Date
June 2 2020
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, France, 94270