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

NCT03368404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-05-14

Study results available
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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

Interventions

DEVICE

CBL-102 eye drops

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

DEVICE

Vismed Multi eye drops

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

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Laboratoire Chauvin

    lead INDUSTRY

Principal Investigators

  • Marc Labetoulle, M.D Ph.D · Hôpital Kremlin-Bicêtre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2020-06-02
Completion
2020-06-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368404 on ClinicalTrials.gov