H Selek1, N Unlü, M Orhan, M Irkeç. 1. Department of Pharmaceutical Technology, Faculty of Pharmacy Hacettepe University, Ankara, Turkey.
Abstract
PURPOSE: An oil in water emulsion of 0.01% all-trans-retinoic acid (tretinoin) was prepared and clinically evaluated in dry eye patients. METHODS: The ophthalmic emulsion consisted of 10% of arachis oil and 90% of the hydrogel of Carbopol 940. To evaluate retinoic acid emulsion clinically, a placebo-controlled, open-labeled, randomized study was performed with 22 dry-eye patients. Symptoms were recorded before and after the treatments. The Schirmer I test, measurement of tear film break-up time (BUT), rose Bengal and fluorescein staining of cornea and conjunctiva, and mucus fern test were done. RESULTS:Retinoic acid did not improve the dryness, photophobia and foreign body sensation more than placebo. Schirmer test and BUT were significantly improved by retinoic acid treatment. Corneal and conjunctival epithelium maintained their characteristics during the use of retinoic acid, as indicated by rose Bengal and fluorescein staining. CONCLUSIONS:Ophthalmic emulsion of retinoic acid can be suggested as a promising approach for the treatment of dry eye.
RCT Entities:
PURPOSE: An oil in water emulsion of 0.01% all-trans-retinoic acid (tretinoin) was prepared and clinically evaluated in dry eyepatients. METHODS: The ophthalmic emulsion consisted of 10% of arachis oil and 90% of the hydrogel of Carbopol 940. To evaluate retinoic acid emulsion clinically, a placebo-controlled, open-labeled, randomized study was performed with 22 dry-eyepatients. Symptoms were recorded before and after the treatments. The Schirmer I test, measurement of tear film break-up time (BUT), rose Bengal and fluorescein staining of cornea and conjunctiva, and mucus fern test were done. RESULTS:Retinoic acid did not improve the dryness, photophobia and foreign body sensation more than placebo. Schirmer test and BUT were significantly improved by retinoic acid treatment. Corneal and conjunctival epithelium maintained their characteristics during the use of retinoic acid, as indicated by rose Bengal and fluorescein staining. CONCLUSIONS: Ophthalmic emulsion of retinoic acid can be suggested as a promising approach for the treatment of dry eye.