NCT06633471

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

A Single-Center, Double- Masked, Randomized Study Evaluating the Safety and Efficacy of PS Therapy (PST) Tear Substitute Formulations in the Treatment of the Signs and Symptoms of Moderate Dry Eye Disease.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: PS Therapy Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-02-28
• Completion: 2025-04-30
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: Barbados

Regulatory

• FDA-regulated drug study