Evaluation of travoprost as adjunctive therapy in patients with uncontrolled intraocular pressure while using timolol 0.5%.
OBJECTIVE
To evaluate the intraocular pressure-lowering efficacy and safety of travoprost 0.0015% and 0.004%, dosed daily in the evening compared with vehicle, in patients with open-angle glaucoma or ocular hypertension, whose intraocular pressure was not adequately controlled on timolol 0.5% twice daily (twice daily).


METHODS
Subjects who qualified at screening began a run-in period dosing timolol twice daily for 3 weeks. If the subjects had an intraocular pressure of 24 to 36 mm Hg at 8 AM and 21 to 36 mm Hg at 10 AM and 4 pm in at least one eye on timolol, they were randomized to one of two concentrations of travoprost (0.0015% or 0.004%) or vehicle solution every day and were followed for 6 months. Four hundred twenty-six subjects were randomized. The mean intraocular pressure at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher intraocular pressure was used for the analysis.


RESULTS
Mean baseline values (25 mm Hg) for subjects at eligibility (while maintained on timolol) were not significantly different (P <.0001) among the treatment groups. The intraocular pressure was lowered an additional -5.7 to -7.2 mm Hg and -5.1 to -6.7 mm Hg in the travoprost 0.004% and 0.0015% concentrations, respectively. These changes were significantly (P < or =.0001) different from the vehicle group (-1.3 to -2.8 mm Hg). The intraocular pressure range on treatment at all visit times over the 6-month treatment period ranged from 17.9 to 19.2 mm Hg for travoprost 0.004% and 18.3 to 20.1 mm Hg for travoprost 0.0015% compared with 22.4 to 24.1 mm Hg for vehicle. Average hyperemia scores ranged from trace to mild (mean 0.5 on a scale of 0 = none/trace; 1= mild; 2 = moderate; 3 = severe) for all treatment groups. No iris pigmentation changes were observed in any patient during this study. There were no clinically or statistically significant changes from baseline in visual acuity, ocular cells and flare, fundus parameter, cup-to-disk ratio and visual field between the treatment groups. There were no serious adverse events reported for any treatment group.


CONCLUSIONS
Travoprost produced clinically relevant and statistically significant additional intraocular pressure reductions from baseline when used adjunctively with timolol in subjects with open-angle glaucoma or ocular hypertension.
Orengo-Nania
S
S
Department of Ophthalmology, Cullen Eye Institute, Baylor College of Medicine, 6565 Fannin, NC-205, Houston, TX 77030, USA. silviao@bcm.tmc.edu
Landry
T
T
Von Tress
M
M
Silver
L H
LH
Weiner
A
A
Davis
A A
AA
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012449:Safety; D013999:Timolol / Q000008:administration & dosage / Q000627:therapeutic use*; D000069557:Travoprost
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D003008:Cloprostenol; D013999:Timolol; D000069557:Travoprost