Efficacy, Safety, and Tolerability of a Novel Cyclosporine, a Formulation for Dry Eye Disease: A Multicenter Phase II Clinical Study

• Published in: Clinical therapeutics Vol. 43; no. 3; pp. 613 - 628
• Main Authors: Peng, Wen-yan, Chen, Rong-xin, Dai, Hong, Zhu, Lei, Li, Ying, Gao, Zi-qing, Li, Xiao-yi, Zhou, Shi-you
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2021; Elsevier Limited
• Subjects: Adverse events; Burning; Chronic fatigue syndrome; Clinical trials; Cornea; cyclosporine; Cyclosporins; Dosage; Drug dosages; dry eye disease; efficacy; Eye diseases; Fluorescein; Immunomodulators; Internal Medicine; multicenter Phase II clinical study; Patients; Pruritus; Safety; Statistical analysis; Surgery; tolerability; United States > US; China; cyclosporine; dry eye disease; multicenter Phase II clinical study; safety; efficacy; tolerability

The purpose of this study was to explore the efficacy, safety, and tolerability of a novel cyclosporine formulation for dry eye disease (DED). This is an exploratory, multicenter, single-blind, randomized, positive-controlled Phase II clinical trial between cyclosporine ophthalmic gel (CyclAGel) and...