Twenty-four-hour intraocular pressure control with the travoprost/timolol maleate fixed combination compared with travoprost when both are dosed in the evening in primary open-angle glaucoma.
OBJECTIVE
To evaluate the 24 h efficacy and safety of the travoprost/timolol maleate fixed combination (TTFC) versus travoprost when both are dosed in the evening in primary open-angle glaucoma patients.


METHODS
Prospective, double-masked, crossover, active-controlled, randomised 24 h comparison. After a 6 week medicine-free period, patients were randomised to either TTFC or travoprost for 8 weeks and were then switched to the opposite treatment for another 8 weeks. At the end of the washout and treatment periods, a 24 h pressure curve was performed.


RESULTS
Thirty-two patients completed the study. The TTFC group demonstrated a lower absolute intraocular pressure level (2.4 mm Hg) for the 24 h curve and at all time points, compared with travoprost (p</=0.047). The pressure reduction from untreated baseline was significantly different between treatments for all time points (p = 0.018). The mean 24 h pressure fluctuation was lower with TTFC (3.0 mm Hg) compared with travoprost (4.0 mm Hg, p = 0.001). No statistical difference existed between the two treatment groups for any adverse event (p>0.05).


CONCLUSIONS
This study suggests that when both drugs are dosed in the evening the TTFC provides improved intraocular pressure reduction, compared with travoprost, over the 24 h curve and for each individual time point in primary open-angle glaucoma patients.
Konstas
A G P
AG
PRN Pharmaceutical Research Network, LLC, 5001 LBJ Freeway, Suite 700, Dallas, TX 75244, USA. info@prnorb.com
Mikropoulos
D
D
Haidich
A-B
AB
Ntampos
K S
KS
Stewart
W C
WC
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002940:Circadian Rhythm; D003008:Cloprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D004338:Drug Combinations; D003008:Cloprostenol; D013999:Timolol; D000069557:Travoprost