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 |
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
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
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