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

NCT02975102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-06-24

Study results available
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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

Interventions

DEVICE

CBL-101 Eye Drops

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

DEVICE

Vismed® Multi Eye Drops

Vismed® Multi 3 to 6 times per day for 3 months.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Laboratoire Chauvin

    lead INDUSTRY

Principal Investigators

  • Raphaele Siou Mermet, MD · Laboratoire Chauvin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • Belgium
  • 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 NCT02975102 on ClinicalTrials.gov