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To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).
A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of PR013 Topical Ophthalmic Drops (0.045% and 0.06%) Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR013 topical Ophthalmic Drops (0.045%) | Active Comparator | topical Ophthalmic Drops (0.045%) |
|
| PR013 topical Ophthalmic Drops (0.06%) | Active Comparator | topical Ophthalmic Drops (0.06%) |
|
| Vehicle | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PR013 (0.045%) | Drug | PR013 topical Ophthalmic Drops (0.045%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itching evaluated by the subject | The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale | [Time Frame: Efficacy assessment period (Day 7 through Day 8)] |
| Conjunctival redness evaluated by the Investigator | Ora Calibra(TM) Ocular Hyperemia Scale | [Time Frame: Efficacy assessment period (Day 7 through Day 8)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Cesano, MD | Essa Pharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Principal Investigator | Philadelphia | Pennsylvania | 19148 | United States |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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Double-Masked
| PR013 (0.06%) | Drug | PR013 topical Ophthalmic Drops (0.06%) |
|
|
| Vehicle | Drug | Vehicle |
|
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |