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



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:January 2, 2018
End Date:July 11, 2018

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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

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


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;
We found this trial at
6
sites
Memphis, Tennessee
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Andover, Massachusetts 01810
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Andover, MA
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Indianapolis, Indiana 46290
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Indianapolis, IN
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181 Russell Street
Lewiston, Maine 04240
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Lewiston, ME
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Raynham, Massachusetts 02767
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Raynham, MA
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Waterbury, Connecticut 06708
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Waterbury, CT
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