Evaluation of travoprost as adjunctive therapy in patients with uncontrolled intraocular pressure while using timolol 0.5%☆
Section snippets
Methods
This prospective, multicenter, double-masked, randomized, parallel group study was conducted in accordance with the principles set forth in the Declaration of Helsinki. Subjects or their legal representative read, signed, and dated an institutional review board-approved consent form before undergoing a screening examination and participation in the study.
The study population consisted of subjects of any race and either sex. Women were required to be 1 year postmenopausal or to have been
Results
Four hundred twenty-seven subjects were randomized to travoprost 0.0015% (n = 142), travoprost 0.004% (n = 145), and vehicle (n = 139). Seventeen subjects had no data recorded while on treatment and thus were excluded from the intent-to-treat analysis (three in 0.0015%, nine in 0.004%, and five in vehicle groups).
Sixty-five subjects were excluded from the per protocol analysis because of protocol violations (20 in 0.0015%, 23 in 0.004%, and 22 in vehicle groups), which included nonqualifying
Discussion
To our knowledge, this is the largest and longest controlled, clinical trial assessing the ability of a prostaglandin analogue to further lower intraocular pressure when used adjunctively with timolol. Significant additional intraocular pressure reductions from baseline of up to 28% were observed with both concentrations of travoprost in subjects whose intraocular pressure remained high despite timolol therapy.
Although the mechanism(s) of action of travoprost has not been determined, it is
Travoprost study group investigators
Walter Atlas, MD, Nalle Clinic, Charlotte, NC 28207; Mark G. Bearman, MD, Eastern Ophthalmic Associates, Inc, Birmingham, AL 35235; Donald Brotherman, MD, Texas Eye Care Associates, Dallas, TX 75234; Delmar Caldwell, MD, Tulane University Medical Center, New Orleans, LA 02112; Robert Caine, MD, Access Eye Centers, Fredericksburg, VA 22405; Hersh Chopra, MD, Georgia Eye Specialists, Marietta, GA 30060; Charles Eugene Cox, MD, Fort Myers, FL 33901; E. Randy Craven, MD, Glaucoma Consultants of CO,
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This study was supported by Alcon Research, Ltd. Dr Orengo-Nania was a clinical investigator for this study and has no proprietary interest in travoprost or any other product in this manuscript. Proprietary rights for travoprost are retained by Alcon Research, Ltd., 6201 S. Freeway, Fort Worth, Texas 76134.