PMID- 15823775
OWN - NLM
STAT- MEDLINE
DCOM- 20050428
LR  - 20151119
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 26
IP  - 12
DP  - 2004 Dec
TI  - Effects of travoprost 0.004% ophthalmic solution, six weeks after its laminated 
      packaging had been removed, in primary open-angle glaucoma: a randomized, 
      controlled, investigator-blinded study.
PG  - 2121-7
AB  - BACKGROUND: Primary open-angle glaucoma (POAG) is a chronic and progressive optic 
      nerve and retinal nerve fiber layer neuropathy, with characteristic visual field 
      damage. The intraocular pressure (IOP) is typically higher than the level 
      considered statistically normal. Although there is no known cure, appropriate 
      reduction of IOP with hypotensive drugs (eg, the topical prostaglandin analogue 
      travoprost) delays the progression of POAG. Chemical-stability studies of 
      travoprost performed by the manufacturer suggest that the stability of travoprost 
      is maintained beyond the expiration date, which is 6 weeks after the laminated 
      packaging has been opened. OBJECTIVE: The goal of this study was to assess the 
      efficacy and tolerability of travoprost 0.004% ophthalmic solution, 6 to 12 weeks 
      after its expiration date, in patients with POAG. METHODS: This randomized, 
      controlled, investigator-blinded study was conducted at 2 centers in Brazil: the 
      Ophthalmology Department, Federal University of Goias, Goiania, and the 
      Ophthalmology Department, Santa Casa de Misericordia Hospital in Sao Jose do Rio 
      Preto, Sao Paulo. Patients with POAG (in 1 or both eyes) were randomly assigned 
      to receive travoprost, either from a bottle from which the laminated packaging 
      had been removed and that had been stored at room light and temperature for 6 
      weeks (ie, after the expiration date; opened group), or from a bottle that had 
      been sealed until first use by the patient (control group). Drug was to be 
      administered, 1 drop in the lower conjunctival sac (in the affected eye[s]), QD 
      between 7 pm and 9 pm, for 6 weeks. IOP was measured at study weeks 0 (baseline), 
      4, and 6. The 2 treatment groups were compared with regard to hypotensor effect 
      and incidence of adverse events (AEs). RESULTS: : Thirty-one patients completed 
      the study (55 eyes; 28 right and 27 left eyes; 35 eyes of women, 20 eyes of men). 
      The mean (SD) ages of the opened and control groups were 61.8 (13.5) and 62.8 
      (14.1) years, respectively. Twenty-four patients were included in both treatment 
      groups (ie, 1 eye per group). The baseline IOP was similar between the 2 
      treatment groups. There was a significant reduction in IOP in both groups at 4 
      and 6 weeks (both, P < 0.001 vs baseline). However, no significant differences in 
      IOP were found between the 2 treatment groups at any time during the study. 
      Conjunctive hyperemia and a burning sensation in the eye immediately after 
      application were the only AEs reported; the incidence of these was similar 
      between the 2 treatment groups. CONCLUSIONS: In this study of patients with POAG, 
      IOPs and AEs were similar in eyes receiving 6 weeks of treatment with travoprost 
      0.004% ophthalmic solution, either from bottles from which the laminated 
      packaging had been opened and that had been stored at room light and temperature 
      for 6 weeks (ie, after the expiration date), or from bottles that had been sealed 
      until first use by the patient. These results suggest that travoprost remains 
      effective for at least 12 weeks after the laminated packaging has been opened.
FAU - Reis, Ricardo
AU  - Reis R
AD  - Ophthalmology Department, Federal University of Goias, Goiania, Brazil.
FAU - dos Santos, Lucia Cristina
AU  - dos Santos LC
FAU - Vila, Marcos P
AU  - Vila MP
FAU - Magacho, Leopoldo
AU  - Magacho L
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Ophthalmic Solutions)
RN  - 4208238832 (Cloprostenol)
RN  - WJ68R08KX9 (Travoprost)
SB  - IM
MH  - Cloprostenol/adverse effects/*analogs & derivatives/*therapeutic use
MH  - Conjunctivitis/chemically induced
MH  - Drug Stability
MH  - Drug Storage
MH  - Female
MH  - Glaucoma, Open-Angle/*drug therapy
MH  - Humans
MH  - Intraocular Pressure/*drug effects
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/adverse effects/*therapeutic use
MH  - Product Packaging
MH  - Travoprost
EDAT- 2005/04/13 09:00
MHDA- 2005/04/29 09:00
CRDT- 2005/04/13 09:00
PHST- 2004/10/07 00:00 [accepted]
PHST- 2005/04/13 09:00 [pubmed]
PHST- 2005/04/29 09:00 [medline]
PHST- 2005/04/13 09:00 [entrez]
AID - S0149-2918(04)00076-1 [pii]
AID - 10.1016/j.clinthera.2004.12.006 [doi]
PST - ppublish
SO  - Clin Ther. 2004 Dec;26(12):2121-7. doi: 10.1016/j.clinthera.2004.12.006.