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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Xiidra® (5% lifitegrast ophthalmic solution); Drug: Reproxalap Ophthalmic Solution (0.25%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05102409

ADX-102-DED-025

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Reproxalap Ophthalmic Solution (0.25%)

Experimental group

Description:

Single dose

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Xiidra® (5% lifitegrast ophthalmic solution)

Active Comparator group

Description:

Single dose

Treatment:

Drug: Xiidra® (5% lifitegrast ophthalmic solution)