title: Ocular surface evaluation in patients treated with a fixed combination of prostaglandin analogues with 0.5% timolol maleate topical monotherapy: a randomized clinical trial.
abstract: OBJECTIVE
  To compare ocular surface changes induced via glaucoma treatment in patients using fixed combinations of prostaglandin analogues (travoprost, latanoprost and bimatoprost) with 0.5% timolol maleate
  
  
  METHODS
  A prospective, multicenter, randomized, parallel group, single-blind clinical trial was performed in 33 patients with ocular hypertension or open angle glaucoma who had not been previously treated. The ocular surface was evaluated prior to and three months after treatment, with a daily drop instillation of one of the three medications. The main outcome measurements included the tear film break-up time, Schirmer's test, Lissamine green staining, the Ocular Surface Disease Index questionnaire, impression cytology using HE and PAS and immunocytochemistry for interleukin-6 and HLA-DR. Ensaiosclinicos.gov.br: UTN - U1111-1129-2872 RESULTS: All of the drugs induced a significant reduction in intraocular pressure. Decreases in the Schirmer's test results were observed with all of the drugs. Decreases in tear-film break-up time were noted with travoprost/timolol and latanoprost/timolol. An increase in the Lissamine green score was noted with travoprost/timolol and bimatoprost/timolol. The Ocular Surface Disease Index score increased after treatment in the travoprost/timolol group. Impression cytology revealed a significant difference in cell-to-cell contact in the same group, an increase in cellularity in all of the groups and an increase in the number of goblet cells in all of the groups. The fixed combinations induced an increase in IL-6 expression in the travoprost/timolol group, in which there was also an increase in HLA-DR expression.
  
  
  CONCLUSIONS
  All of the fixed combinations induced a significant reduction in intraocular pressure, and the travoprost/timolol group showed increased expression of the inflammatory markers HLA-DR and interleukin-6. All three tested medications resulted in some degree of deterioration in the ocular surface after three months of glaucoma treatment.
authors.affiliation: Glaucoma Department, Graefe Institute of Ophthalmology, CuritibaPR, Brazil.
authors.forename: Heloisa Helena
authors.initials: HH
authors.lastname: Russ
authors.forename: Pedro Antônio
authors.initials: PA
authors.lastname: Nogueira-Filho
authors.forename: Jeison de Nadai
authors.initials: Jde N
authors.lastname: Barros
authors.forename: Nubia Vanessa Lima de
authors.initials: NV
authors.lastname: Faria
authors.forename: Fabiano
authors.initials: F
authors.lastname: Montiani-Ferreira
authors.forename: José Álvaro Pereira
authors.initials: JÁ
authors.lastname: Gomes
authors.forename: Paulo Augusto Arruda
authors.initials: PA
authors.lastname: Mello
mesh_terms: D000368:Aged; D000577:Amides / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D000069580:Bimatoprost; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D005123:Eye / Q000187:drug effects*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006684:HLA-DR Antigens / Q000032:analysis; D006801:Humans; D007150:Immunohistochemistry; D015850:Interleukin-6 / Q000032:analysis; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage; D011465:Prostaglandins, Synthetic / Q000008:administration & dosage*; D016037:Single-Blind Method; D013999:Timolol / Q000008:administration & dosage*; D000069557:Travoprost; D016896:Treatment Outcome
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D004338:Drug Combinations; D006684:HLA-DR Antigens; D015850:Interleukin-6; D011461:Prostaglandins F, Synthetic; D011465:Prostaglandins, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D013999:Timolol; D000069580:Bimatoprost; D000069557:Travoprost