Efficacy of latanoprost when stored at room temperature. 2008

Hideki Mochizuki, and Hideki Itakura, and Michiya Takamatsu, and Yoshiaki Kiuchi
Department of Ophthalmology and Visual Science, Hiroshima University, Minami-ku, Hiroshima, Japan.

We compared the ocular hypotensive effect for 24 hours and the tolerability of latanoprost stored at 4 degrees C and 30 degrees C. Seventeen healthy volunteers were included in this crossover trial. Latanoprost 0.005% (Xalatan) was stored at 4 degrees C or 30 degrees C for 4 weeks in the dark. The subjects enrolled to the study were randomly assigned to receive either latanoprost stored at 4 degrees C or that stored at 30 degrees C. The eye drop was applied to the right eye of each subject for 3 days. The left eye served as a control without administration. Slit-lamp biomicroscopy and circadian intra ocular pressure (IOP) curve was performed at Day 3, every 3 hours from 6 pm. This procedure was repeated 7 days after changing the drug from 4 degrees C to 30 degrees C or vice versa, and application to the left eye for 3 days. Eyes treated with latanoprost, stored both at 4 degrees C and 30 degrees C, achieved statistically significantly lower mean IOPs than untreated eyes at all time points, except at 21 hours treated by the drug stored at 30 degrees C. We subtracted the IOP of eyes receiving latanoprost from the IOP of untreated eyes for each time point to evaluate the efficacy of the eye drops (delta IOP). There were no statistically significant differences between the delta IOPs with the drug stored at 4 degrees C and 30 degrees C. During the study, no subject developed a serious adverse event. These results suggest that latanoprost stored at 30 degrees C for 4 weeks after opening the bottle remains as effective and safe as latanoprost stored under cold conditions.

UI MeSH Term Description Entries
D007429 Intraocular Pressure The pressure of the fluids in the eye. Ocular Tension,Intraocular Pressures,Ocular Tensions,Pressure, Intraocular,Pressures, Intraocular,Tension, Ocular,Tensions, Ocular
D008297 Male Males
D009883 Ophthalmic Solutions Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. Eye Drop,Eyedrop,Eyedrops,Ophthalmic Solution,Eye Drops,Drop, Eye,Drops, Eye,Solution, Ophthalmic,Solutions, Ophthalmic
D011461 Prostaglandins F, Synthetic Analogs or derivatives of prostaglandins F that do not occur naturally in the body. They do not include the product of the chemical synthesis of hormonal PGF. PGF Synthetic,Prostaglandin F Analogs,Prostaglandin F Analogues,Synthetic Prostaglandins F,Analogs, Prostaglandin F,Analogues, Prostaglandin F,Synthetic, PGF
D003080 Cold Temperature An absence of warmth or heat or a temperature notably below an accustomed norm. Cold,Cold Temperatures,Temperature, Cold,Temperatures, Cold
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D005260 Female Females
D005901 Glaucoma An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed) Glaucomas
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077338 Latanoprost A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA. PHXA41,PhXA34,Xalatan

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