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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2022-05-09

Brief Summary

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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

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reproxalap Ophthalmic Solution (0.25%)

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type DRUG

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

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type DRUG

Vehicle Ophthalmic Solution dosed six times over two consecutive days

Interventions

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Reproxalap Ophthalmic Solution (0.25%)

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

Intervention Type DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution dosed six times over two consecutive days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No