A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-07-11

Brief Summary

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A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) 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 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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%) administered for approximately twelve weeks.

Reproxalap Ophthalmic Solution (0.1%)

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.1%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type DRUG

Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Interventions

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Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.1%)

Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.

Intervention Type DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age of either gender and any race;
* Have a reported history of dry eye for at least 6 months prior to Visit 1;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Exclusion Criteria

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No