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Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness

NCT03517748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-05-07

No results posted yet for this study

Summary

This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, 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

DM05 eye drops

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

DEVICE

Optive™ 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

  • Christophe Baudouin, Pr · Hopital d Ophtalmologie des Quinze-vingts

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2018-01-02
Completion
2018-03-30

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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 NCT03517748 on ClinicalTrials.gov