Clinical Trial: Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival

Brief Summary: The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome:

• Ocular Itching [ Time Frame: over all study visits post CAC for up to 2 weeks ]
• Conjunctival redness [ Time Frame: over all study visits post CAC for up to 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Symptoms [ Time Frame: at visit 2 (Day 2), post-dose ]
  Allergy symptoms evaluated by subject.
• Symptoms [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ]
  Allergy symptoms evaluated by subject
• Signs [ Time Frame: at visit 2 (Day 2), post-dose ]
  Allergy signs evaluated by investigator
• Signs [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ]
  Allergy signs evaluated by investigator

Original Secondary Outcome: Same as current

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: February 1, 2011
Date Started: February 2011
Date Completion:
Last Updated: November 22, 2013
Last Verified: November 2013