A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

Summary

Study of safety and efficacy of UNR844 in subjects with presbyopia.

Timeline

Start

2021-06-30

Primary completion

2022-07-27

Completion

2022-10-14

Outcome

Missed primary endpoint

Stopped: “The study was discontinued by the Sponsor because it did not achieve the primary objective.”

registry UNR844 5 mg/mL vs Placebo Ophthalmic Solution; p = 0.817 NCT04806503 ↗

registry UNR844 13.3 mg/mL vs Placebo Ophthalmic Solution; p = 0.946 NCT04806503 ↗

registry UNR844 23 mg/mL vs Placebo Ophthalmic Solution; p = 0.380 NCT04806503 ↗

registry UNR844 30 mg/mL vs Placebo Ophthalmic Solution; p = 0.667 NCT04806503 ↗

release “Ph2b dose ranging study evaluating safety and efficacy in patients aged 45-55 years with presbyopia did not meet its primary endpoint” novartis.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARLIPOIC ACID CHOLINE ESTER	Small molecule	5 mg/ml	Topical
Subject	ARLIPOIC ACID CHOLINE ESTER	Small molecule	13.3 mg/ml	Topical
Subject	ARLIPOIC ACID CHOLINE ESTER	Small molecule	23 mg/ml	Topical
Subject	ARLIPOIC ACID CHOLINE ESTER	Small molecule	30 mg/ml	Topical

Indications