PMID- 29680880
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2193-8245 (Print)
IS  - 2193-6528 (Electronic)
VI  - 7
IP  - 1
DP  - 2018 Jun
TI  - A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% 
      Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% 
      Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with 
      Controlled Primary Open-Angle Glaucoma.
PG  - 145-156
LID - 10.1007/s40123-018-0128-8 [doi]
AB  - INTRODUCTION: The aim of this prospective crossover study was to evaluate the 
      non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 
      0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by 
      evaluating its efficacy, tolerability and safety in subjects with controlled 
      primary open-angle glaucoma (POAG) previously treated with KOF for at least 
      2 months. METHODS: In a prospective, crossover, randomized, double-masked 
      multicenter study, patients previously treated with KOF were randomly assigned to 
      receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to 
      KOF, while the B sequence received PRO-122. All patients remained in the protocol 
      for 30 additional days for a total of 60 days. The main efficacy endpoint was 
      maintaining the controlled intraocular pressure (IOP). The safety and 
      tolerability of both products were assessed by the presence of adverse events 
      (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. 
      RESULTS: A total of 51 patients participated. After application of PRO-122 twice 
      a day, its efficacy was demonstrated through maintenance of the controlled IOP in 
      patients previously controlled with KOF. The crossover between PRO-122 and KOF 
      and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was 
      shown not to be inferior to KOF in maintaining IOP at control levels. The safety 
      of both drugs is similar, as neither presented drug-related AEs or differences 
      regarding safety issues. The tolerability of the two medications-evaluated by 
      ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also 
      determined to be similar. CONCLUSIONS: The controlled IOP in patients with 
      controlled POAG treated with PRO-122 was maintained both in relation to the 
      initial controlled IOP of the study and when compared with KOF in the B sequence. 
      Finally, the treatment with PRO-122 demonstrated similar safety and tolerability 
      to KOF. FUNDING: Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, Mexico). 
      TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03257813 (registered 
      retrospectively).
FAU - Gomez-Aguayo, Francisco
AU  - Gomez-Aguayo F
AD  - Private Practice, Guadalajara, Jalisco, Mexico.
FAU - Paczka, Jose A
AU  - Paczka JA
AD  - Unidad de Diagnostico Temprano del Glaucoma, Zapopan, Jalisco, Mexico.
AD  - Global Glaucoma Institute, Guadalajara, Jalisco, Mexico.
AD  - Instituto de Oftalmologia y Ciencias Visuales, CUCS, Universidad de Guadalajara, 
      Guadalajara, Jalisco, Mexico.
FAU - Lenero-Cordova, Ruben
AU  - Lenero-Cordova R
AD  - Hospital San Jose Para Enfermos de la Vista A.C., Guadalajara, Jalisco, Mexico.
FAU - Jimenez-Roman, Jesus
AU  - Jimenez-Roman J
AD  - Asociacion para Evitar la Ceguera en Mexico (APEC), Mexico City, Mexico.
FAU - Davila-Villarreal, Jaime
AU  - Davila-Villarreal J
AD  - Servicios Medicos Quirurgicos de Monterrey, S.C., Monterrey, Nuevo Leon, Mexico.
FAU - Hartleben, Curt
AU  - Hartleben C
AD  - Fundacion de Asistencia Privada Conde de Valenciana, I.A.P., Mexico City, Mexico.
FAU - Baiza-Duran, Leopoldo
AU  - Baiza-Duran L
AD  - Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
FAU - Olvera-Montano, Oscar
AU  - Olvera-Montano O
AD  - Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
FAU - Garcia-Velez, Francisco
AU  - Garcia-Velez F
AD  - Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
FAU - Munoz-Villegas, Patricia
AU  - Munoz-Villegas P
AUID- ORCID: 0000-0002-7559-1218
AD  - Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. 
      patricia.munoz@sophia.com.mx.
LA  - eng
SI  - ClinicalTrials.gov/NCT03257813
PT  - Journal Article
DEP - 20180421
PL  - England
TA  - Ophthalmol Ther
JT  - Ophthalmology and therapy
JID - 101634502
PMC - PMC5997590
OTO - NOTNLM
OT  - Benzalkonium chloride
OT  - Fixed combination preservative-free
OT  - Intraocular pressure
OT  - Primary open-angle glaucoma
EDAT- 2018/04/24 06:00
MHDA- 2018/04/24 06:01
PMCR- 2018/04/21
CRDT- 2018/04/23 06:00
PHST- 2018/03/02 00:00 [received]
PHST- 2018/04/24 06:00 [pubmed]
PHST- 2018/04/24 06:01 [medline]
PHST- 2018/04/23 06:00 [entrez]
PHST- 2018/04/21 00:00 [pmc-release]
AID - 10.1007/s40123-018-0128-8 [pii]
AID - 128 [pii]
AID - 10.1007/s40123-018-0128-8 [doi]
PST - ppublish
SO  - Ophthalmol Ther. 2018 Jun;7(1):145-156. doi: 10.1007/s40123-018-0128-8. Epub 2018 
      Apr 21.