Tomohiro Ogami1, Hiroki Asano2, Takahiro Hiraoka3, Yoshiaki Yamada4, Tetsuro Oshika5. 1. Ibaraki Seinan Medical Center Hospital, Ibaraki, Japan. 2. Tsuchiura Kyodo General Hospital Namegata District Medical Center, Ibaraki, Japan. 3. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan. thiraoka@md.tsukuba.ac.jp. 4. Japan Medical Affairs, Development Management Department, Japan Business, Santen Pharmaceutical Co., Ltd., Osaka, Japan. 5. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan.
Abstract
INTRODUCTION: This study evaluated the efficacy and safety of diquafosol ophthalmic solution (DQS) in soft contact lens (SCL)-related dry eye using artificial tear as a control. METHODS: This study enrolled 26 patients with SCL-related dry eye. DQS and artificial tears (AT) were instilled into the right and left eyes, respectively, with their SCLs on. Dry eye examinations (including tear film breakup time, tear volume, and staining score) were performed and visual function (including contrast sensitivity) was also evaluated before (at baseline) and after treatment (at 4- and 8-week examinations). Subjective symptoms were assessed separately in each eye using a questionnaire on dry eye in contact lens wearers. The results were compared before and after treatment, and between the right eyes treated with DQS (the DQS eye) and the left eyes treated with AT (the AT eye) using the mixed effect model. RESULTS: Corneal and conjunctival staining scores at 8-week examination were significantly lower than those at baseline in the DQS eye (p = 0.03; p < 0.001, respectively), but no significant changes were observed in the AT eye. Most subjective symptoms improved significantly in both the DQS and AT eyes. However, major subjective symptoms (dryness and blurry vision) improved significantly only in the DQS eye at 8-week examination. Contrast sensitivity at 8-week examination in the DQS eye improved significantly at 12 cycles/degree compared to baseline (p = 0.001) and was significantly better than that in the AT eye (p = 0.03). There were no adverse events related to DQS or AT. CONCLUSIONS: DQS was effective and safe for SCL-related dry eye. DQS also improved contrast sensitivity. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), Identification No. UMIN000024064.
INTRODUCTION: This study evaluated the efficacy and safety of diquafosol ophthalmic solution (DQS) in soft contact lens (SCL)-related dry eye using artificial tear as a control. METHODS: This study enrolled 26 patients with SCL-related dry eye. DQS and artificial tears (AT) were instilled into the right and left eyes, respectively, with their SCLs on. Dry eye examinations (including tear film breakup time, tear volume, and staining score) were performed and visual function (including contrast sensitivity) was also evaluated before (at baseline) and after treatment (at 4- and 8-week examinations). Subjective symptoms were assessed separately in each eye using a questionnaire on dry eye in contact lens wearers. The results were compared before and after treatment, and between the right eyes treated with DQS (the DQS eye) and the left eyes treated with AT (the AT eye) using the mixed effect model. RESULTS: Corneal and conjunctival staining scores at 8-week examination were significantly lower than those at baseline in the DQS eye (p = 0.03; p < 0.001, respectively), but no significant changes were observed in the AT eye. Most subjective symptoms improved significantly in both the DQS and AT eyes. However, major subjective symptoms (dryness and blurry vision) improved significantly only in the DQS eye at 8-week examination. Contrast sensitivity at 8-week examination in the DQS eye improved significantly at 12 cycles/degree compared to baseline (p = 0.001) and was significantly better than that in the AT eye (p = 0.03). There were no adverse events related to DQS or AT. CONCLUSIONS: DQS was effective and safe for SCL-related dry eye. DQS also improved contrast sensitivity. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), Identification No. UMIN000024064.
Authors: P Ewen King-Smith; Jason J Nichols; Kelly K Nichols; Barbara A Fink; Richard J Braun Journal: Optom Vis Sci Date: 2008-08 Impact factor: 1.973