24-Hour IOP control with once-daily bimatoprost, timolol gel-forming solution, or latanoprost: a 1-month, randomized, comparative clinical trial.
OBJECTIVE
To compare the efficacy and safety of once-daily (QD) bimatoprost, latanoprost, and timolol gel-forming solution in providing 24-hour intraocular pressure (IOP) control.


METHODS
This was a randomized, multicenter, investigator-masked, prospective, parallel-group, clinical trial.


METHODS
Patients with open-angle glaucoma or ocular hypertension.


METHODS
After washout of any previous ocular hypotensive medications, patients were randomly assigned to treatment with bimatoprost 0.03% ophthalmic solution QD (n=38) or latanoprost 0.005% ophthalmic solution QD (n=38) between 7 and 9 pm, or timolol maleate 0.5% gel-forming ophthalmic solution QD (n=39) between 7 and 9 am for 1 month.


METHODS
The primary outcome measure, circadian IOP, was measured at eight time points over the course of 24 hours beginning at 8 am on day 28 and with the last measurement at 8 am on day 29. IOP was also measured at 8 am and 10 am at baseline and at 8 am on day 14. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure.


RESULTS
At 10 am (peak drug effect) on day 28, the mean IOP reduction from baseline was significantly greater with bimatoprost (9.3 mm Hg, 40.3%) than with timolol gel (7.1 mm Hg, 31.1%; P=.024, Wilcoxon rank sum test) or latanoprost (7.4 mm Hg, 33.3%). In the overall analysis of IOP measured over the course of 24 hours, mean IOP was significantly lower with bimatoprost or latanoprost than with timolol gel (P<.001; analysis of repeated measures). The analysis of repeated measures also showed a significant difference between bimatoprost and latanoprost (P=.003). In the area-under-the-curve analysis, bimatoprost and latanoprost were superior to timolol gel (P< or =.018) but comparable to each other (P> or =.223). All treatment regimens were well tolerated, with few discontinuations due to adverse events. There were no significant effects on systemic safety parameters.


CONCLUSIONS
Once-daily bimatoprost or latanoprost provided significantly better 24-hour IOP control than timolol gel in patients with glaucoma or ocular hypertension. Some measurements suggested a trend for greater efficacy of bimatoprost over latanoprost. All three treatments were well tolerated.
Walters
Thomas R
TR
Keystone Research, Austin, Texas, USA.
DuBiner
Harvey B
HB
Carpenter
Susan P
SP
Khan
Bashir
B
VanDenburgh
Amanda M
AM
D000577:Amides; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D000069580:Bimatoprost; D002940:Circadian Rhythm / Q000187:drug effects*; D003008:Cloprostenol / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005782:Gels; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008055:Lipids / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D013999:Timolol / Q000627:therapeutic use*; D016896:Treatment Outcome
D000577:Amides; D000959:Antihypertensive Agents; D005782:Gels; D008055:Lipids; D011461:Prostaglandins F, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D013999:Timolol; D000069580:Bimatoprost