Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Subjects.
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|ClinicalTrials.gov Identifier: NCT01959243|
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : July 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperemia||Drug: Brimonidine Tartrate Drug: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||507 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Geriatric Subjects.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Brimonidine Tartrate
Brimonidine tartrate ophthalmic solution 0.025%, one drop of drug into each eye, four times daily for up to four weeks.
Drug: Brimonidine Tartrate
Placebo Comparator: Vehicle
Vehicle of brimonidine tartrate ophthalmic solution, one drop of vehicle into each eye, four times daily, for up to four weeks.
- Adverse Events [ Time Frame: Overall visits to Visit 4 (Day 36) ]Comparison of adverse events in the treated group vs vehicle group
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959243
|United States, New Jersey|
|Bausch & Lomb Incorporated|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Quintus Ngumah, OD, PhD||Bausch & Lomb Incorporated|