Hypotensive effect of latanoprost/timolol versus travoprost/timolol fixed combinations in NTG patients: a randomized, multicenter, crossover clinical trial.
OBJECTIVE
To compare the ocular hypotensive effect of travoprost plus timolol (TTFC) and latanoprost plus timolol fixed combinations (LTFC) in patients with normal-tension glaucoma (NTG).


METHODS
A two-sequence 12-week, multicenter, prospective, randomized, single-blinded, crossover clinical trial examined 59 NTG patients. If both eyes were eligible, only one eye (chosen at random) was used for analytical purposes. After a 12-week run-in period with dorzolamide plus timolol fixed combination (DTFC), patients were randomized into one of the two crossover sequences of treatment for 12 weeks with TTFC or LTFC and were subsequently crossed over to the alternative treatment for a further 12 weeks. The primary endpoint was reduction in IOP after 12 weeks of each treatment sequence. The effect of treatment on IOP was assessed using a linear mixed model.


RESULTS
The mean baseline IOP was 14.8 ± 3.3 mm Hg (95% confidence interval [CI], 14.1-15.3 mm Hg) for treatment with DTFC. The TTFC treatment period showed consistently lower mean IOP compared with LTFC treatment period at all measurement time points. Mean reduction in IOP at 12 weeks was significantly greater in the TTFC group than in the LTFC group (-2.4 ± 2.3 mm Hg vs. -1.1 ± 2.3 mm Hg; P = 0.021). No interaction between the drug and treatment sequence was detected. The effects of intraocular lens implantation and measurement time were also not significant. The tolerability profiles of both treatments were similar.


CONCLUSIONS
The additional reduction in IOP was greater with TTFC than with LTFC, and their tolerability profiles were similar. (http://www.umin.ac.jp/ctr/ number, UMIN 000005974.).
Department of Ophthalmology, Saitama Medical University, Iruma, Saitama, Japan.
Takuhei
T
Shoji
Hiroki
H
Sato
Atsushi
A
Mizukawa
Naoto
N
Hirota
Toshio
T
Enoki
Teruo
T
Kojima
Takayuki
T
Kanda
Masaru
M
Takeuchi
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D003008:Cloprostenol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D057066:Low Tension Glaucoma / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D016037:Single-Blind Method; D013999:Timolol / Q000627:therapeutic use*; D000069557:Travoprost
D000959:Antihypertensive Agents; D011461:Prostaglandins F, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D013999:Timolol; D000069557:Travoprost
fixed combination; normal-tension glaucoma; randomized study