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

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

• Registration Number: NCT05424549
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Status Verified: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cliantha Research; 🇨🇦 Mississauga, Ontario, Canada