BACKGROUND AND OBJECTIVE: This study evaluates the effectiveness of Akten (Akorn, Inc., Buffalo Grove, IL), a novel ophthalmic gel anesthetic agent for complete ocular anesthesia. PATIENTS AND METHODS: This study was conducted as a prospective, randomized, double-blinded, multicenter Phase III clinical trial to evaluate Akten gel. The study had four cohorts of subjects who received sham gel, Akten 1.5%, Akten 2.5%, and Akten 3.5%, respectively. Subjects were assessed for achievement of anesthesia at defined time intervals and questioned for "pain" or "no pain" following pinching of the conjunctiva with 0.3-mm forceps at predetermined intervals. RESULTS:A total of 209 subjects were entered into the study. The percentages of patients achieving the primary endpoint (ie, anesthesia within 5 minutes) were as follows: 22% for sham, 88% for Akten 1.5%, 89% for Akten 2.5%, and 92% for Akten 3.5%, respectively. Safety measures including corneal staining, conjunctival hyperemia, and eye pain with administra-tion were low and comparable in all cohorts. CONCLUSION: Akten gel appears to be an effective and safe ocular anesthetic. All doses were well tolerated and no dose-related corneal toxicity was observed.
RCT Entities:
BACKGROUND AND OBJECTIVE: This study evaluates the effectiveness of Akten (Akorn, Inc., Buffalo Grove, IL), a novel ophthalmic gel anesthetic agent for complete ocular anesthesia. PATIENTS AND METHODS: This study was conducted as a prospective, randomized, double-blinded, multicenter Phase III clinical trial to evaluate Akten gel. The study had four cohorts of subjects who received sham gel, Akten 1.5%, Akten 2.5%, and Akten 3.5%, respectively. Subjects were assessed for achievement of anesthesia at defined time intervals and questioned for "pain" or "no pain" following pinching of the conjunctiva with 0.3-mm forceps at predetermined intervals. RESULTS: A total of 209 subjects were entered into the study. The percentages of patients achieving the primary endpoint (ie, anesthesia within 5 minutes) were as follows: 22% for sham, 88% for Akten 1.5%, 89% for Akten 2.5%, and 92% for Akten 3.5%, respectively. Safety measures including corneal staining, conjunctival hyperemia, and eye pain with administra-tion were low and comparable in all cohorts. CONCLUSION: Akten gel appears to be an effective and safe ocular anesthetic. All doses were well tolerated and no dose-related corneal toxicity was observed.