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Evaluation of Efficacy and Safety of Vismed Gel Multi 0.3% Versus Vismed Multi 0.18% on Treatment of Ocular Dryness

NCT03645850 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-24

No results posted yet for this study

Summary

This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.

Conditions

  • Dry Eye

Interventions

DEVICE

Vismed gel Multi 0.3% eye drops

Ophthalmic use. Vismed gel Multi 0.3% eye drops. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

DEVICE

Vismed Multi 0.18% eye drops

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Sponsors & Collaborators

  • Horus Pharma

    lead INDUSTRY

Principal Investigators

  • Béatrice Cochener-Lamard, Prof · Hôpital Morvan, Brest, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-03-01
Completion
2019-06-15

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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 NCT03645850 on ClinicalTrials.gov