Clinical Trial: Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects With Ocular Redness.

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

Official Title: Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness

Brief Summary: To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for treating ocular redness in a population of adult and geriatric participants with ocular redness.

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Ocular Redness - Investigator [ Time Frame: 240 minutes ]

Ocular redness evaluated by the investigator prior to investigational drug instillation and up to 240 minutes post investigational drug instillation (0-4 unit scale, allowing half unit increments) at Visit 1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ocular Redness - Participant [ Time Frame: 5 Weeks ]
    Ocular redness evaluated by the participant as captured in participants' diaries (0-4 unit scale, NOT allowing half unit increments).
  • Ocular Redness - Investigator [ Time Frame: Visit 1 (Day 1) and Visit 2 (Day 15) and Visit 3 (Day 29) ]
    Ocular redness evaluated by the investigator prior to investigational drug instillation and at up to 480 minutes post investigational drug instillation at Visit 1; 5 minutes post investigational drug instillation at Visits 2 and 3.(0-4 unit scale, allowing half unit increments)


Original Secondary Outcome: Same as current

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: October 8, 2013
Date Started: November 2013
Date Completion:
Last Updated: July 24, 2014
Last Verified: July 2014