title: Additive effects and safety of fixed combination therapy with 1% brinzolamide and 0.5% timolol versus 1% dorzolamide and 0.5% timolol in prostaglandin-treated glaucoma patients.
abstract: OBJECTIVE
  To compare the additive effects and safety of 1% brinzolamide/0.5% timolol fixed combination (BTFC) versus the low-dose regimen of 1% dorzolamide/0.5% timolol fixed combination (DTFC) in patients with open-angle glaucoma and ocular hypertension (OAG/OH) following treatment with prostaglandin analogues (PGAs).
  
  
  METHODS
  A prospective, randomized, double-masked, multicentre, parallel-group and active-controlled study included 201 Japanese OAG/OH patients who had been treated with PGA. Efficacy was assessed as the change in intra-ocular pressure (IOP) from baseline after weeks 4 and 8. Safety was assessed with adverse event rates, ocular discomfort score, blur scale, blood pressure and heart rates, best-corrected visual acuity (BCVA) and slit lamp examinations.
  
  
  RESULTS
  Intra-ocular pressure (IOP) change from baseline at 9 AM/11 AM pooled over the 8 weeks was -3.3/-3.3 mmHg in the BTFC group and -2.9/-3.4 mmHg in the DTFC group, demonstrating non-inferiority of BTFC to DTFC. Ocular irritation was frequently seen in DTFC group. Although blurred vision was frequently seen in BTFC group, it was transient and blurring became the equivalent 3 min after instillation between two groups. No noteworthy issue was observed in other safety outcome.
  
  
  CONCLUSIONS
  Non-inferiority of BTFC to DTFC in IOP reduction was demonstrated after adding onto PGA therapy in Japanese OAG/OH patients. Although the score of blurred vision was transiently higher in BTFC than DTFC, treatment difference decreased and disappeared with time. Thus, BTFC can be considered as a safe and effective agent for glaucoma treatment.
authors.affiliation: Department of Ophthalmology, University of Tokyo, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Aihara
authors.affiliation: Eye Rose Clinic, Tokyo, Japan.
authors.forename: Misato
authors.initials: M
authors.lastname: Adachi
authors.affiliation: Matsuo Eye Clinic, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Matsuo
authors.affiliation: Department of Ophthalmology, Niigata University Medical and Dental Hospital, Niigata, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Togano
authors.affiliation: Department of Ophthalmology, Niigata University Medical and Dental Hospital, Niigata, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Fukuchi
authors.affiliation: Alcon Japan Ltd., Tokyo, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Sasaki
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D007429:Intraocular Pressure / Q000187:drug effects*; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011446:Prospective Studies; D011465:Prostaglandins, Synthetic / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D013843:Thiazines / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D013997:Time Factors; D013999:Timolol / Q000008:administration & dosage*; D014065:Tonometry, Ocular; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D009883:Ophthalmic Solutions; D011465:Prostaglandins, Synthetic; D013449:Sulfonamides; D013843:Thiazines; D013876:Thiophenes; C479140:dorzolamide-timolol combination; D013999:Timolol; C111827:brinzolamide
keywords: brinzolamide; dorzolamide; fixed combination; glaucoma; intra-ocular pressure