A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2022-10-11

Brief Summary

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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease

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Detailed Description

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Conditions

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Dry Eye Disease

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 (0.25%) for six weeks

Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).

Vehicle for six weeks

Vehicle QID for four weeks followed by BID for two weeks

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).

Reproxalap (0.25%) for 12 months

Reproxalap (0.25%) QID for four weeks followed by BID for 11 months

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).

Vehicle for 12 months

Vehicle QID for four weeks followed by BID for 11 months

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

Interventions

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Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).

Intervention Type DRUG

Placebo Comparator

Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).

Intervention Type DRUG

Placebo Comparator

Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria

* 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;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* 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