Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects With Ocular Redness.
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|ClinicalTrials.gov Identifier: NCT01959230|
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 :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Experimental: Brimonidine Tartrate
Brimonidine tartrate ophthalmic solution 0.025%, one drop of drug into each eye, four times daily for up to 30 days.
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 30 days.
- 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.
- 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)
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): NCT01959230
|United States, New Jersey|
|Bausch & Lomb Incorporated|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Quintus Ngumah, OD, PhD||Bausch & Lomb Incorporated|