title: Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension.
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.
authors.affiliation: Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China. zhaojialiang@medmail.com.cn
authors.forename: Jia-Liang
authors.initials: JL
authors.lastname: Zhao
authors.forename: Jian
authors.initials: J
authors.lastname: Ge
authors.forename: Xiao-Xin
authors.initials: XX
authors.lastname: Li
authors.forename: Yu-Min
authors.initials: YM
authors.lastname: Li
authors.forename: Yao-Hua
authors.initials: YH
authors.lastname: Sheng
authors.forename: Nai-Xue
authors.initials: NX
authors.lastname: Sun
authors.forename: Xing-Huai
authors.initials: XH
authors.lastname: Sun
authors.forename: Ke
authors.initials: K
authors.lastname: Yao
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhong
mesh_terms: D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002681:China / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D006801:Humans; D015994:Incidence; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D009883:Ophthalmic Solutions; D015995:Prevalence; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage*; D012189:Retrospective Studies; D013997:Time Factors; D013999:Timolol / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D013999:Timolol