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Open Access Highly Accessed Research article

Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension

Jia-Liang Zhao1*, Jian Ge2, Xiao-Xin Li3, Yu-Min Li4, Yao-Hua Sheng5, Nai-Xue Sun6, Xing-Huai Sun7, Ke Yao8, Zheng Zhong9 and the Xalacom Study Group in China

Author Affiliations

1 Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China

2 Zhong Shan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China

3 Beijing University People's Hospital, Beijing, China

4 Zhe Jiang University, 1st Hospital, Hangzhou, China

5 Shanghai Jiaotong University, Xin Hua Hospital of Medical School, Shanghai, China

6 Xi'an Jiao Tong University, 2nd Hospital, Xi'an, China

7 Eye & ENT Hospital of Fudan University, Shanghai, China

8 Zhe Jiang University, 2nd Hospital, Hangzhou, China

9 Medical Affairs, Pfizer Investment Co. Ltd., China

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BMC Ophthalmology 2011, 11:23  doi:10.1186/1471-2415-11-23

Published: 19 August 2011

Abstract

Background

A noninferiority trial was conducted to evaluate the efficacy of a single evening dose of fixed-combination latanoprost 50 μg/mL and timolol 0.5 mg/mL (Xalacom®; LTFC), in Chinese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who were insufficiently controlled on β-blocker monotherapy or β-blocker-based dual therapy.

Methods

This 8-week, randomized, open-label, parallel-group, noninferiority study compared once-daily evening dosing of LTFC with the unfixed combination of latanoprost, one drop in the evening, and timolol, one drop in the morning (LTuFC). The primary efficacy endpoint was the mean change from baseline to week 8 in diurnal intraocular pressure (IOP; mean of 8 AM, 10 AM, 2 PM, 4 PM IOPs). LTFC was considered noninferior to LTuFC if the upper limit of the 95% confidence interval (CI) of the difference was < 1.5 mmHg (analysis of covariance).

Results

Baseline characteristics were similar for LTFC (N = 125; POAG, 70%; mean IOP, 25.8 mmHg) and LTuFC (N = 125; POAG, 69%; mean IOP, 26.0 mmHg). Mean diurnal IOP changes from baseline to week 8 were -8.6 mmHg with LTFC and -8.9 mmHg with LTuFC (between-treatment difference: 0.3 mmHg; 95%-CI, -0.3 to 1.0). Both treatments were well tolerated.

Conclusions

A single evening dose of LTFC was at least as effective as the unfixed combination of latanoprost in the PM and timolol in the AM in reducing IOP in Chinese subjects with POAG or OH whose IOP was insufficiently reduced with β-blocker monotherapy or β-blocker-based dual therapy. LTFC is an effective and well tolerated once-daily treatment for POAG and OH.

Trial registration

Clinicaltrials.gov registration: NCT00219596