NCT04201574

Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Allysta Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

Detailed description

This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	ALY688 0.1%	ALY688 0.1% Ophthalmic Solution
DRUG	ALY688 0.4%	ALY688 0.4% Ophthalmic Solution
DRUG	Vehicle	Vehicle Ophthalmic Solution

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2019-12-17
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study