Yuta Saito1,2, Junichiro Kizaki3,4, Yoshihiro Wada3,4, Yoshiyuki Shibasaki5, Nobuharu Kishimoto5, Makoto Aihara6. 1. Shinanozaka Clinic, Tokyo, Japan. s-yuta@med.showa-u.ac.jp. 2. Department of Ophthalmology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan. s-yuta@med.showa-u.ac.jp. 3. Shinanozaka Clinic, Tokyo, Japan. 4. Department of Ophthalmology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan. 5. Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan. 6. Department of Ophthalmology, University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Abstract
PURPOSE: To evaluate the 24-h efficacy and safety of fixed combination carteolol/latanoprost (LCFC) and timolol/latanoprost (LTFC) in patients with primary open-angle glaucoma and ocular hypertension. STUDY DESIGN: Prospective, randomized, crossover study METHODS:Twenty-two patients pretreated with a prostaglandin analog at baseline were randomly assigned at a 1:1 ratio to either LCFC or LTFC treatment. The patients received the assigned study drug in both eyes daily in the evening (20:00). Each treatment group crossed over after a 2-month treatment period. The 24-h curves of intraocular pressure (IOP), pulse rate, and blood pressure were evaluated. Safety was also assessed. RESULTS: The changes in mean daytime IOP from baseline at the end of the 2-month treatment period in the LCFC and LTFC groups were - 0.93 and - 1.15 mmHg, respectively. The changes in peak IOP in the 2 groups were - 0.91 and - 0.68 mmHg, respectively. The nighttime pulse rate in the LCFC group increased; that in the LTFC group was lower at all time points. The changes in pulse rate from baseline at 22:00, 2:00, 4:00, and 6:00 differed statistically between the 2 groups. No differences in changes from baseline in systolic and diastolic blood pressures were found between the groups. CONCLUSION: The 24-h IOP curve of patients in the LCFC group was similar to that of the LTFC group, but on the basis of the pulse rate findings, the effect of LCFC on the cardiovascular system over 24 h was less than that of LTFC.
RCT Entities:
PURPOSE: To evaluate the 24-h efficacy and safety of fixed combination carteolol/latanoprost (LCFC) and timolol/latanoprost (LTFC) in patients with primary open-angle glaucoma and ocular hypertension. STUDY DESIGN: Prospective, randomized, crossover study METHODS: Twenty-two patients pretreated with a prostaglandin analog at baseline were randomly assigned at a 1:1 ratio to either LCFC or LTFC treatment. The patients received the assigned study drug in both eyes daily in the evening (20:00). Each treatment group crossed over after a 2-month treatment period. The 24-h curves of intraocular pressure (IOP), pulse rate, and blood pressure were evaluated. Safety was also assessed. RESULTS: The changes in mean daytime IOP from baseline at the end of the 2-month treatment period in the LCFC and LTFC groups were - 0.93 and - 1.15 mmHg, respectively. The changes in peak IOP in the 2 groups were - 0.91 and - 0.68 mmHg, respectively. The nighttime pulse rate in the LCFC group increased; that in the LTFC group was lower at all time points. The changes in pulse rate from baseline at 22:00, 2:00, 4:00, and 6:00 differed statistically between the 2 groups. No differences in changes from baseline in systolic and diastolic blood pressures were found between the groups. CONCLUSION: The 24-h IOP curve of patients in the LCFC group was similar to that of the LTFC group, but on the basis of the pulse rate findings, the effect of LCFC on the cardiovascular system over 24 h was less than that of LTFC.