A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

NCT02975102 | Completed Results

• 1 other identifier: 2016-A01121-50
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Dry Eye

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 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)

Secondary Outcomes (18)

• Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)

  Baseline (Day 0), Visit 3 (Day 7)

• 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 7 (Visit 3)

  Baseline (Day 0), Visit 3 (Day 7)

• Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)

  Baseline (Day 0), Visit 4 (Day 28)

• Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)

  Baseline (Day 0), Visit 5 (Day 90)

Study Arms (2)

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.

Device: CBL-101 Eye Drops

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.

Device: Vismed® Multi Eye Drops

Interventions

CBL-101 Eye Drops DEVICE

CBL-101 Eye Drops 3 to 6 times per day for 3 months.

CBL-101 Eye Drops

Vismed® Multi Eye Drops DEVICE

Vismed® Multi 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:

• 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 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

You may not qualify if:

• 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:
• Lid abnormality (except mild blepharitis)
• Corneal disease
• Ocular surface metaplasia
• Filamentary keratitis
• Corneal neovascularization
• 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
• 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

Sponsors & Collaborators

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

Study Sites (2)

Dr. Nyst private office

Huy, Belgium

Location

Pr Mortemousque private office

Bordeaux, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 36269661 RESULT

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

• Raphaele Siou Mermet, MD

  Laboratoire Chauvin

  STUDY DIRECTOR

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 21, 2016
• First Posted: November 29, 2016
• Study Start: March 1, 2017
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); BE (1)