Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial.
OBJECTIVE
To compare the safety, tolerability, and efficacy of bimatoprost 0.03% instilled once daily or twice daily with timolol 0.5% twice daily.


METHODS
Multicenter, 3-month, randomized, double-masked, interventional comparison trial.


METHODS
Patients diagnosed with ocular hypertension or glaucoma (n = 596).


METHODS
Patients received bimatoprost 0.03% ophthalmic solution once daily (8 PM, with vehicle control at 8 AM), bimatoprost 0.03% twice daily (8 AM; 8 PM), or timolol 0.5% twice daily (8 AM; 8 PM) in an uneven 2:2:1 randomization. Scheduled visits were at prestudy, baseline (day 0), weeks 2 and 6, and month 3. Intraocular pressure (IOP) was measured at 8 AM (predose), 10 AM, and 4 PM.


METHODS
The primary outcome measure was reduction in IOP in the eye with higher IOP at baseline. Secondary outcome measures included safety variables (adverse events, ophthalmoscopy, biomicroscopy, iris pigmentation, laser-flare meter, visual acuity, visual fields, heart rate, blood pressure, blood chemistry, hematology, and urinalysis).


RESULTS
At month 3, the mean reduction in IOP from baseline at 8 AM was 9.16 mmHg (35.2%) with bimatoprost once daily, 7.78 mmHg (30.4%) with bimatoprost twice daily, and 6.74 mmHg (26.2%) with timolol twice daily. At all follow-up visits, mean IOP reductions were significantly greater in the bimatoprost once daily group than in the timolol group at each time point (8 AM, 10 AM, and 4 PM; P < 0.001). Twice-daily dosing of bimatoprost also provided significantly greater mean reductions in IOP than timolol at most time points but was not as effective as once-daily dosing. Bimatoprost was associated with significantly more hyperemia and eyelash growth than timolol, whereas timolol was associated with significantly more burning and stinging sensation in eyes. Overall, bimatoprost was well tolerated with few discontinuations because of adverse events.


CONCLUSIONS
Bimatoprost 0.03% once daily was safe and statistically superior to timolol 0.5% twice daily in lowering IOP in patients with ocular hypertension or glaucoma. Bimatoprost given once daily consistently provided IOP reductions approximately 2 to 3 mmHg greater than those provided by timolol. Once-daily dosing of bimatoprost, 0.03%, demonstrated greater IOP-lowering effect and better ocular tolerability than twice-daily dosing.
Brandt
J D
JD
Department of Ophthalmology, University of California at Davis, Sacramento, California 95817-2307, USA.
VanDenburgh
A M
AM
Chen
K
K
Whitcup
S M
SM
D000328:Adult; D000577:Amides; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D000069580:Bimatoprost; D003008:Cloprostenol / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005901:Glaucoma / Q000188:drug therapy; D006439:Hemodynamics; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008055:Lipids / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D009883:Ophthalmic Solutions; D012449:Safety; D013999:Timolol / Q000008:administration & dosage*; D016896:Treatment Outcome; D014792:Visual Acuity; D014794:Visual Fields
D000577:Amides; D000959:Antihypertensive Agents; D008055:Lipids; D009883:Ophthalmic Solutions; D003008:Cloprostenol; D013999:Timolol; D000069580:Bimatoprost