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A Study of ADX-102 in Subjects With Allergic Conjunctivitis
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.
Details
| Lead sponsor | Aldeyra Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 154 |
| Start date | 2016-12 |
| Completion | 2017-05 |
Conditions
- Conjunctivitis, Allergic
Interventions
- ADX-102 Ophthalmic Drops (0.5%)
- ADX-102 Ophthalmic Drops (0.1%)
- Vehicle of ADX-102 Ophthalmic Drops
Primary outcomes
- Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. — Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. - Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. — Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. - Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. — Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Countries
United States