Clinical Trial: Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Subjects.

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

Official Title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% in a Population of Pediatric, Adult, and Ge

Brief Summary: To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51% of subjects will be 40 years of age or older.

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Adverse Events [ Time Frame: Overall visits to Visit 4 (Day 36) ]

Comparison of adverse events in the treated group vs vehicle group


Original Primary Outcome: Adverse Events [ Time Frame: Overall visits to Visit 4 (Day 29) ]

Comparison of adverse events in the treated group vs vehicle group


Current Secondary Outcome:

  • Drop Comfort [ Time Frame: Visit 1 (Day 1) ]
    Measured on a scale of 0-10.
  • Alertness [ Time Frame: Visit 2 (Day 15), Visit 3 (Day 29), and Visit 4 (Day 36) ]
    Alertness measured at 90-180 minutes after administration of the test product using a 6 point alertness scale.


Original Secondary Outcome: Drop Comfort [ Time Frame: Visit 1 (Day 1) ]

Measured on a scale of 0-10.


Information By: Bausch & Lomb Incorporated

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