Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure - A 6-month, masked, multicenter trial

被引:90
作者
Fellman, RL
Sullivan, EK
Ratliff, M
Silver, LH
Whitson, JT
Turner, FD
Weiner, AL
Davis, AA
机构
[1] Glaucoma Associates Texas, Dallas, TX USA
[2] Alcon Res Ltd, Ft Worth, TX USA
[3] Univ Texas, SW Med Ctr, Dept Ophthalmol, Dallas, TX USA
关键词
D O I
10.1016/S0161-6420(02)01010-2
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Objective: To compare the safety and intraocular pressure (IOP)-lowering efficacy of once-daily travoprost (0.0015% and 0.004%) to twice-daily timolol 0.5%. Design: Prospective, 6-month, randomized, controlled, multicenter, double-masked, phase III study. Participants: Six hundred five patients with open-angle glaucoma or ocular hypertension. Methods: Patients with an 8 AM IOP between 24 to 36 mmHg in at least one eye (the same eye) at two eligibility visits received either travoprost 0.0015%, travoprost 0.004% (dosed every day), or timolol 0.5% (dosed twice daily). Main Outcome Measures: Mean IOP at 8 AM, 10 AM, and 4 Pm in the patient's eyewith the higher baseline IOP. Results: The mean IOP was significantly lower for both concentrations of travoprost compared with timolol. Travoprost was statistically superior to timolol at 9 of 13 visits, with differences in IOP reductions ranging from 0.9 to 1.8 mmHg (0.0015%) and 10 of 13 visits with differences in IOP reductions from 0.9 to 2.4 mmHg (0.004%). Mean IOP changes from baseline ranged from -6.0 to -7.5 mmHg (0.0015%), -6.5 to -8.0 mmHg (0,004%), and -5.2 to -7.0 mmHg for timolol. Hyperemia was experienced at rates of 29.2% (59 of 202) for travoprost 0.0015%, 42.8% (86 of 201) for travoprost 0.004%, and 8.9% (18 of 202) for timolol. Iris pigmentation changes were observed in 1.0% (2 of 200) of patients receiving travoprost 0.004% with no changes noted in the travoprost 0.0015% group or the timolol group. A decrease in pulse and systolic blood pressure was observed in the timolol group. There were no other clinically relevant or statistically significant changes from baseline in ocular signs or laboratory values, and no serious, related, unexpected adverse events were reported for any group. Conclusions: Travoprost (0.0015% and 0.004%), dosed once daily in the evening, is statistically superior or equal to timolol 0.5% dosed twice daily at all treatment visits during this 6-month study. IOP reductions of up to 2.0 mmHg greater than timolol were found in the travoprost 0.004% pooled data group. Travoprost is safe and well tolerated in patients with open-angle glaucoma or ocular hypertension. (C) 2002 by the American Academy of Ophthalmology.
引用
收藏
页码:998 / 1008
页数:11
相关论文
共 24 条
[1]   Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning - A comparison with timolol [J].
Alm, A ;
Stjernschantz, J ;
Widengard, I ;
Linden, C ;
Soderstrom, M ;
Nilsson, SE ;
Fristrom, B ;
Lindblom, B ;
Heijl, A ;
Gundersen, KG ;
Ehinger, B ;
Holmin, C ;
BengtssonStigmar, E ;
Aasved, H ;
Jangard, P ;
Ringvold, A ;
Vegge, T ;
Halseide, R ;
LundAndersen, H ;
Flesner, P ;
Thygesen, J ;
Airaksinen, J ;
Tuulonen, A .
OPHTHALMOLOGY, 1995, 102 (12) :1743-1752
[2]  
Alward WL, 1998, AM J OPHTHALMOL, V126, P498
[3]   CARDIOVASCULAR EFFECTS OF TOPICAL BETA-BLOCKERS DURING EXERCISE [J].
ATKINS, JM ;
PUGH, BR ;
TIMEWELL, RM .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 1985, 99 (02) :173-175
[4]  
BACON PJ, 1989, BRIT J CLIN PHARMACO, V27, P1
[6]   ALTERNATION OF LUNG-FUNCTION DUE TO TIMOLOL, METIPRANOLOL, PINDOLOL AND PILOCARPIN EYE-DROPS IN PATIENTS WITH MILD ASTHMA BRONCHIALE AND NORMAL ADULTS [J].
BOHM, E ;
FABEL, H .
KLINISCHE WOCHENSCHRIFT, 1987, 65 (19) :920-924
[7]   Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP -: A 3-month clinical trial [J].
Brandt, JD ;
VanDenburgh, AM ;
Chen, K ;
Whitcup, SM .
OPHTHALMOLOGY, 2001, 108 (06) :1023-1031
[8]   Latanoprost-associated cystoid macular edema [J].
Callanan, D ;
Fellman, RL ;
Savage, JA .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 1998, 126 (01) :134-135
[9]  
*CPMP, 1999, CPMPEWP48299
[10]   Quantitative autoradiographic visualization and pharmacology of FP-prostaglandin receptors in human eyes using the novel phosphor-imaging technology [J].
Davis, TL ;
Sharif, NA .
JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS, 1999, 15 (04) :323-336