This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Sponsored by Aldeyra Therapeutics, Inc.

About this trial

Last updated 3 years ago

Study ID

ADX-102-DED-027

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

What are the participation requirements?

Yes

Inclusion Criteria

1. Eighteen (18) to 70 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 screening

4. Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

No

Exclusion Criteria

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening

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

3. Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period

4. Women of childbearing potential (WOCBP) who are pregnant and nursing

5. If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.

6. Known allergy and/or sensitivity to reproxalap or the drug product vehicle

7. 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

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

Locations

Location

Status