title: A 12-week, double-masked, parallel-group study of the safety and efficacy of travoprost 0.004% compared with pilocarpine 1% in Chinese patients with primary angle-closure and primary angle-closure glaucoma.
abstract: OBJECTIVE
  To examine the intraocular pressure-lowering efficacy and safety of travoprost 0.004% and pilocarpine 1% in Chinese patients with primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) after laser iridotomy in China.
  
  
  METHODS
  Thirty patients with PAC or PACG after laser iridotomy were randomized into this double-masked, parallel-group study. Qualified patients had a mean intraocular pressure (IOP) between 21 and 35 mm Hg; inclusive at 9 AM at eligibility visit and previously undergone laser peripheral iridotomy at least 30 days before screening visit. Patients were treated with travoprost 0.004% once daily or pilocarpine 1% 4 times daily for 12 weeks after appropriate washout of glaucoma medications. Efficacy and safety evaluations were conducted at weeks 4, 8, and 12. IOP measurements were performed at 9 AM and 4 PM at baseline and week 12 visits, except at the weeks 4 and 8, when the IOP measurement was undertaken respectively at 9 AM or 4 PM only. The degree and distribution of peripheral anterior synechiae was evaluated by gonioscopy at baseline and week 12, respectively.
  
  
  RESULTS
  Both the treatment groups showed statistically significant IOP reductions from baseline, except for the results of pilocarpine group at 4 PM in week 12. Travoprost demonstrated a statistically superior IOP reduction (7.6 mm Hg) compared with pilocarpine (1.9 mm Hg; P=0.04) at 4 PM over the 12-week period. There was no difference in peripheral anterior synechiae degree and distribution in week 12 from baseline for both treatment groups. No serious adverse event was found in both the groups.
  
  
  CONCLUSIONS
  Travoprost 0.004% once daily provides effective IOP-lowering efficacy with significantly greater IOP reduction from baseline when compared with pilocarpine 1% 4 times daily at 4 PM over the 12-week period. Travoprost 0.004% once daily is safe and well tolerated in PAC or PACG patients.
authors.affiliation: Peking University Third Hospital, Peking University Eye Center, Beijing, China. wullc@hotmail.com
authors.forename: Ling Ling
authors.initials: LL
authors.lastname: Wu
authors.forename: Ping
authors.initials: P
authors.lastname: Huang
authors.forename: Yan Xiu
authors.initials: YX
authors.lastname: Gao
authors.forename: Zhi Xin
authors.initials: ZX
authors.lastname: Wang
authors.forename: Benny
authors.initials: B
authors.lastname: Li
mesh_terms: D000368:Aged; D000869:Anterior Eye Segment / Q000187:drug effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People / Q000208:ethnology; D002681:China / Q000453:epidemiology; D003008:Cloprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D015812:Glaucoma, Angle-Closure / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D006068:Gonioscopy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D032801:Iridectomy; D007498:Iris / Q000601:surgery; D053685:Laser Therapy; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D010862:Pilocarpine / Q000008:administration & dosage* / Q000009:adverse effects; D014065:Tonometry, Ocular; D000069557:Travoprost; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D010862:Pilocarpine; D003008:Cloprostenol; D000069557:Travoprost