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A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental |
| |
| Vehicle Ophthalmic Solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reproxalap ophthalmic solution (0.25%) | Drug | Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported ocular discomfort score over Week 1 to Week 6 | Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort" | From Day -14 to Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Core, Inc. | Shelby | North Carolina | 28150 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Vehicle ophthalmic solution | Drug | Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks |
|