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Clinical Study Aimed At Evaluating the Safety and Efficacy of Tear Substitute Formulations in the Treatment of Dry Eye Disease.

NCT06633471 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-10-09

No results posted yet for this study

Summary

This clinical study is aimed at evaluating the safety and effectiveness of 2 test formulations (Rain and Mist), against an approved over-the-counter formulation (Systane Ultra) and a placebo (saline), in the treatment of moderate dry eye disease.

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).

Rain and Mist are the test formulations. Systane Ultra is an approved OTC formulation. Saline is the placebo.

Sponsors & Collaborators

  • PS Therapy Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-02-28
Completion
2025-04-30
FDA Drug
Yes

Countries

  • Barbados

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 NCT06633471 on ClinicalTrials.gov