Study of ST-100 as Treatment for Dry Eye Disease

Status Completed

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.

Clinical Trial Description

This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1): - Low dose ST-100 Ophthalmic Solution: 1 drop twice daily (BID) in each eye - High dose ST-100 Ophthalmic Solution: 1 drop BID in each eye - Placebo Ophthalmic Solution (Vehicle): 1 drop BID in each eye Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment. The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms of dry eye. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05241470
Study type	Interventional
Source	Stuart Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	May 17, 2021
Completion date	October 11, 2021

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