NCT05102409

An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) dosed once
DRUG	Xiidra® (5% lifitegrast ophthalmic solution)	Xiidra® (5% lifitegrast ophthalmic solution) dosed once

Timeline

• Start date: 2021-09-09
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2021-11-01
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study