An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.
• Treatments: Lifitegrast; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Eighteen (18) to70 years of age at the time of screening (either gender and any race).

2. Ability to provide written informed consent.

3. Reported history of dry eye for at least 6 months prior to Visit 1.

Exclusion Criteria:

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1.

2. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.

3. A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial.

4. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.