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Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye Dryness

NCT06245421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-02-13

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 DM934 in comparison with Théalose 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

DM934

1 drop in each eye, 4 to 6 times per day

DEVICE

Théalose

1 drop in each eye, 4 to 6 times per day

Sponsors & Collaborators

  • Eurofins Dermscan Pharmascan

    collaborator INDUSTRY

  • Horus Pharma

    lead INDUSTRY

Principal Investigators

  • Ewa Paw, MD · Eurofins Dermscan Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-08-12
Completion
2024-09-30

Countries

  • France
  • Poland
  • Spain
  • United Kingdom

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 NCT06245421 on ClinicalTrials.gov