Brimonidine 0.2% vs unoprostone 0.15% both added to timolol maleate 0.5% given twice daily to patients with primary open-angle glaucoma or ocular hypertension.
OBJECTIVE
To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15%, both added to timolol maleate 0.5% each given twice daily.


METHODS
In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6-week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period.


RESULTS
In all, 33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3+/-2.4 and the diurnal curve IOP was 22.0+/-1.3 mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6+/-3.3 and the diurnal curve IOP was 19.8+/-2.1 mmHg, while the timolol and unoprostone treatment showed a trough IOP of 20.9+/-3.8 and a diurnal curve IOP of 19.3+/-2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve, or in the reduction from baseline (P>0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800 h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P<0.0001) with unoprostone by survey.


CONCLUSIONS
Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve.
Sharpe
E D
ED
Center for Eye Research, Mt. Pleasant, SC, USA.
Henry
C J
CJ
Mundorf
T K
TK
Day
D G
DG
Stewart
J A
JA
Jenkins
J N
JN
Stewart
W C
WC
D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068438:Brimonidine Tartrate; D018592:Cross-Over Studies; D015237:Dinoprost / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011446:Prospective Studies; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D011810:Quinoxalines; D000068438:Brimonidine Tartrate; C072630:isopropyl unoprostone; D013999:Timolol; D015237:Dinoprost