Makoto Aihara1, Yoko Ikeda, Shiro Mizoue, Yoshikuni Arakaki, Naofumi Kita, Satoshi Kobayashi. 1. *Department of Ophthalmology, University of Tokyo †Shirato Eye Clinic, Tokyo ‡Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto §Department of Ophthalmology, Ehime University, Ehime ∥Department of Ophthalmology, University of Ryukyus, Okinawa ¶Eguchi Eye Hospital, Hakodate #Department of Ophthalmology, Yokohama City University Medical Center, Yokohama **Yokohama Hodogaya Central Hospital, Yokohama, Japan.
Abstract
PURPOSE: To assess the effect of switching 1 eye to topical travoprost 0.004% preserved with SofZia (TRAVATAN Z solution) in patients who had chronic superficial punctate keratitis (SPK) in both eyes treated withbenzalkonium chloride-preserved latanoprost 0.005% (XALATAN). METHODS: This was a prospective, randomized, controlled, multicenter, open-label, comparative 3-month follow-up study. Patients with open-angle glaucoma or ocular hypertension who received XALATAN monotherapy for at least 3 months and had SPK in both eyes were enrolled at 9 facilities. For each patient, 1 eye was randomly selected and switched to TRAVATAN Z solution (T-group); the contralateral control eye was treated with XALATAN (X-group). SPK in 5 corneal regions, conjunctival hyperemia, tear breakup time (TBUT), and intraocular pressure (IOP) were examined in a masked manner at baseline, 1 month, and 3 months. Changes in SPK, hyperemia, TBUT, and IOP were compared within treatment groups and between treatment groups. RESULTS:Fifty-six patients completed the study. The frequency of SPK significantly decreased from baseline in the T-group and the X-group at 1 and 3 months (T-group, P<0.001; X-group, P<0.05). In the T-group, SPK scores were significantly improved in 4 corneal regions, excluding the superior region, at 1 and 3 months (all P<0.05), whereas in the X-group, SPK scores were significantly improved only in the temporal region at 1 month and in the inferior region at 3 months (P<0.05 for both). The total SPK score at 1 and 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0023 and 0.0102, respectively). The SPK score for the superior and central corneal region at 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0212 and 0.022, respectively). There were no substantial intergroup or intragroup differences in changes from baseline for hyperemia scores, TBUT, or IOP reduction. CONCLUSIONS: Switching therapy from benzalkonium chloride-preserved latanoprost to travoprost preserved with SofZia ameliorated chronic SPK. There were no clinically relevant changes in hyperemia, TBUT, or IOP.
RCT Entities:
PURPOSE: To assess the effect of switching 1 eye to topical travoprost 0.004% preserved with SofZia (TRAVATAN Z solution) in patients who had chronic superficial punctate keratitis (SPK) in both eyes treated with benzalkonium chloride-preserved latanoprost 0.005% (XALATAN). METHODS: This was a prospective, randomized, controlled, multicenter, open-label, comparative 3-month follow-up study. Patients with open-angle glaucoma or ocular hypertension who received XALATAN monotherapy for at least 3 months and had SPK in both eyes were enrolled at 9 facilities. For each patient, 1 eye was randomly selected and switched to TRAVATAN Z solution (T-group); the contralateral control eye was treated with XALATAN (X-group). SPK in 5 corneal regions, conjunctival hyperemia, tear breakup time (TBUT), and intraocular pressure (IOP) were examined in a masked manner at baseline, 1 month, and 3 months. Changes in SPK, hyperemia, TBUT, and IOP were compared within treatment groups and between treatment groups. RESULTS: Fifty-six patients completed the study. The frequency of SPK significantly decreased from baseline in the T-group and the X-group at 1 and 3 months (T-group, P<0.001; X-group, P<0.05). In the T-group, SPK scores were significantly improved in 4 corneal regions, excluding the superior region, at 1 and 3 months (all P<0.05), whereas in the X-group, SPK scores were significantly improved only in the temporal region at 1 month and in the inferior region at 3 months (P<0.05 for both). The total SPK score at 1 and 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0023 and 0.0102, respectively). The SPK score for the superior and central corneal region at 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0212 and 0.022, respectively). There were no substantial intergroup or intragroup differences in changes from baseline for hyperemia scores, TBUT, or IOP reduction. CONCLUSIONS: Switching therapy from benzalkonium chloride-preserved latanoprost to travoprost preserved with SofZia ameliorated chronic SPK. There were no clinically relevant changes in hyperemia, TBUT, or IOP.