Efficacy of Changing to TRAVATAN® From Prior Therapy
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|ClinicalTrials.gov Identifier: NCT01510145|
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Open-angle Glaucoma Ocular Hypertension||Drug: Travoprost 0.004% BAK-free||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
U.S. FDA Resources
Experimental: TRAVATAN® BAK-free
Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Drug: Travoprost 0.004% BAK-free
Containing Polyquad (PQ) preservative
Other Name: TRAVATAN® BAK-free
- Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) [ Time Frame: Baseline, Week 12 ]IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
- Percentage of Subjects Who Reach Target IOP (≤18 mmHg) [ Time Frame: Week 12 ]IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
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): NCT01510145
|Study Director:||Adriana S. Bonadia||Alcon Research|