A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

NCT03368404 | Completed Results

• 2 other identifiers: CBL-2017-012017-A01099-44
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

dry eye, tear substitute, ocular lubricant

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• 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)

Study Arms (2)

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

Device: CBL-102 eye drops

Vismed Multi eye drops

ACTIVE COMPARATOR

CE marked medical device, tear substitute containing 0.18% sodium hyaluronate, presented in 10 mL bottles

Device: Vismed Multi eye drops

Interventions

CBL-102 eye drops DEVICE

CBL-102 eye drops, 3 to 6 times per day for 3 months

CBL-102 eye drops

Vismed Multi eye drops DEVICE

Vismed Multi eye drops, 3 to 6 times per day for 3 months

Vismed Multi eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• 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

You may not qualify if:

• Severe blepharitis
• Severe ocular dryness accompanied by 1 of the following:
• Lid abnormality
• Corneal disease
• Ocular surface metaplasia
• Filamentary keratitis
• Corneal neovascularization
• 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

Sponsors & Collaborators

• Laboratoire Chauvin: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Associate Director, Global Clinical Operations
• Organization: Bausch + Lomb

natasa.orlic-pleyer@bausch.com

+49 30 330 93

Study Officials

• Marc Labetoulle, M.D Ph.D

  Hôpital Kremlin-Bicêtre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 11, 2017
• Study Start: November 9, 2017
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)