NCT03088605

Safety and Efficacy of TOP1630 for Dry Eye Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Detailed description

This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome. Eligible subjects will be randomized double masked to either TOP1630 or placebo. Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort. Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	TOP1630 Ophthalmic Solution	Bilateral ocular drug administration
DRUG	Placebo to TOP1630 Ophthalmic Solution	Bilateral ocular drug administration

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-06-15
• Completion: 2017-06-15
• First posted: 2017-03-23
• Last updated: 2024-02-14
• Results posted: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study