NCT05241470

Study of ST-100 as Treatment for Dry Eye Disease

A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Stuart Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	ST-100 Ophthalmic Solution	One drop in each eye twice a day
DRUG	Placebo Ophthalmic Solution	One drop in each eye twice a day

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2022-02-15
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study