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Title: 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.
Author: Reis R, dos Santos LC, Vila MP, Magacho L.
Journal: Clin Ther; 2004 Dec; 26(12):2121-7. PubMed ID: 15823775.
Abstract:
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 Goiás, Goiânia, and the Ophthalmology Department, Santa Casa de Misericordia Hospital in São José 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.

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