PMID- 18035191
OWN - NLM
STAT- MEDLINE
DCOM- 20080108
LR  - 20181201
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 9
DP  - 2007 Sep
TI  - A 6-week, multicenter, randomized, double-masked, parallel-group study comparing 
      travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment 
      with travoprost 0.004%.
PG  - 1915-23
AB  - OBJECTIVE: The aim of this study was to compare the tolerability and efficacy of 
      once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 
      weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in 
      patients with open-angle glaucoma (OAG) or ocular hypertension (OH). METHODS: 
      This multicenter, randomized, doublemasked, active-controlled, parallel-group 
      trial was conducted at 32 centers across Latin America. Patients aged > or =18 
      years with OAG or OH were randomly assigned to receive topical travoprost 0.004% 
      or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, 
      all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 
      PM) for 6 additional weeks (open-label phase). Study visits were scheduled at 
      weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 
      hour; approximately 20 hours after study drug administration). IOP changes from 
      baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a 
      comparison between the 2 treatment groups. Ocular adverse events (AEs) were 
      monitored using slit-lamp examination. RESULTS: A total of 302 patients were 
      enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The 
      mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; 
      and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) 
      years; 62.6% were female; and 49.0% were white. Mean IOP values were not 
      significantly different between the travoprost and latanoprost groups at baseline 
      (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in 
      reductions from baseline in pooled IOP during the masked phase of the study was 
      statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, 
      mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group 
      and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to 
      travoprost (all, P = NS). The most common ocular AEs that occurred with masked 
      travoprost, latanoprost, and open-label travoprost were hyperemia (26.9%, 12.2%, 
      and 5.3%, respectively), discomfort (3.2%, 3.4%, and 1.1%), and pruritus (4.5%, 
      2.0%, and 2.1%). CONCLUSIONS: In this population of patients with OAG or OH, 
      6-week treatment with travoprost 0.004% was associated with a significantly 
      greater decrease from baseline in pooled IOP compared with latanoprost 0.005% 20 
      hours after administration. There were no significant differences between the 2 
      groups. Travoprost and latanoprost were well tolerated.
FAU - Maul, Eugenio
AU  - Maul E
AD  - Pontificia Universidad Catolica, Santiago, Chile.
FAU - Carrasco, Felix Gil
AU  - Carrasco FG
FAU - Costa, Vital Paulino
AU  - Costa VP
FAU - Casiraghi, Javier F
AU  - Casiraghi JF
FAU - Vargas, Enrique
AU  - Vargas E
FAU - Sarmina, Judith S
AU  - Sarmina JS
FAU - Mayol, Renato
AU  - Mayol R
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Prostaglandins F, Synthetic)
RN  - 4208238832 (Cloprostenol)
RN  - 6Z5B6HVF6O (Latanoprost)
RN  - WJ68R08KX9 (Travoprost)
SB  - IM
MH  - Administration, Topical
MH  - Analysis of Variance
MH  - Antihypertensive Agents/*administration & dosage/adverse effects/therapeutic use
MH  - Cloprostenol/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glaucoma/*drug therapy
MH  - Glaucoma, Open-Angle/drug therapy
MH  - Gonioscopy
MH  - Humans
MH  - Intraocular Pressure/drug effects
MH  - Latanoprost
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions
MH  - Prostaglandins F, Synthetic/*administration & dosage/adverse effects/therapeutic 
      use
MH  - Tonometry, Ocular
MH  - Travoprost
MH  - Treatment Outcome
MH  - Visual Acuity
EDAT- 2007/11/24 09:00
MHDA- 2008/01/09 09:00
CRDT- 2007/11/24 09:00
PHST- 2007/06/18 00:00 [accepted]
PHST- 2007/11/24 09:00 [pubmed]
PHST- 2008/01/09 09:00 [medline]
PHST- 2007/11/24 09:00 [entrez]
AID - S0149-2918(07)00287-1 [pii]
AID - 10.1016/j.clinthera.2007.09.006 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Sep;29(9):1915-23. doi: 10.1016/j.clinthera.2007.09.006.