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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05424549

ADX-102-DED-027

Details and patient eligibility

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution