Clinical Trial: A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title:
Brief Summary: 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.
Detailed Summary:
Sponsor: Aldeyra Therapeutics, Inc.
Current Primary Outcome: Ocular itching evaluated by the Subject. [ Time Frame: Efficacy assessment period (Day 3 through Day 15) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ocular redness. [ Time Frame: Efficacy assessment period (Day 3 through Day 15) ]The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale
- Tearing [ Time Frame: Efficacy assessment period (Day 3 through Day 15) ]The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Tearing/Watery Eyes Scale
- Eyelid Swelling [ Time Frame: Efficacy assessment period (Day 3 through Day 15) ]The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Eyelid Swelling Scale
Original Secondary Outcome: Same as current
Information By: Aldeyra Therapeutics, Inc.
Dates:
Date Received: December 14, 2016
Date Started: December 2016
Date Completion:
Last Updated: April 3, 2017
Last Verified: March 2017