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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05424549

Collaborator

(none)

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Vehicle Ophthalmic Solution	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%) Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution Vehicle Ophthalmic Solution dosed six times over two consecutive days

Arm

Intervention/Treatment

Experimental: Reproxalap Ophthalmic Solution (0.25%)

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days

Placebo Comparator: Vehicle Ophthalmic Solution

Drug: Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution dosed six times over two consecutive days

Outcome Measures

Primary Outcome Measures

Change from baseline in conjunctival redness in a dry eye chamber [On the second day of two consecutive dosing days for both crossover periods]
Conjunctival redness assessed on a 9 point scale using half unit increments using the modified Validated Bulbar Redness scale (0 None (better) - 4 Extremely Severe (worse))
Schirmer's test mean change from baseline [On the first day of two consecutive dosing days for both crossover periods]
Assessed using a sterile Schirmer's test strip

Secondary Outcome Measures

Schirmer's test ≥10mm responder analysis of change from baseline [On the first day of two consecutive dosing days for both crossover periods]
Assessed using a sterile Schirmer's test strip

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
Ability to provide written informed consent
Reported history of dry eye for at least 6 months prior to screening
Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion Criteria:

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
Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
Women of childbearing potential (WOCBP) who are pregnant and nursing
If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
Known allergy and/or sensitivity to reproxalap or the drug product vehicle
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
Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits