NCT03833388

Study of TOP1630 for Dry Eye Syndrome

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Topivert Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In subjects with Dry Eye Syndrome (DES): The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

Detailed description

This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES). Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	TOP1630 0.1% Ophthalmic Solution TID OU	Bilateral ocular drug administration
DRUG	Placebo to TOP1630 0.1% Ophthalmic Solution TID OU	Bilateral ocular drug administration

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2019-02-07
• Last updated: 2019-08-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study