Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy
|ClinicalTrials.gov Identifier: NCT01514721|
Recruitment Status : Terminated (low enrollment)
First Posted : January 23, 2012
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
U.S. FDA Resources
Travoprost/Timolol Maleate BAK-Free Fixed Combination, 1 drop self-administered in treated eye(s) once a day for 12 weeks
Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination
Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).
Other Name: DuoTrav®
- Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline) [ Time Frame: 12 weeks ]Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg.
- Percentage of patients who reach target IOP (≤18mmHg) [ Time Frame: 12 weeks ]Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population.
- Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline [ Time Frame: 12 weeks ]An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated.
- Change in ocular hyperemia score at final visit from baseline [ Time Frame: 12 weeks ]Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514721
|Alcon Investigational Site|
|Sao Paulo, Brazil|
|Study Director:||Abayomi Ogundele, PharmD||Alcon Research|