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) ]

The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale


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