A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes

Summary

The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Timeline

Start

2017-11-05

Primary completion

2018-04-09

Completion

2018-04-09

Outcome

Missed primary endpoint

registry analysis (superiority test); 0.10% HL036 Ophthalmic Solution vs Placebo; p = 0.3378; Least Squares (LS) Mean Difference 0.11 (95% CI -0.12 to 0.34); NCT03334539 ↗

registry analysis (superiority test); 0.10% HL036 Ophthalmic Solution vs Placebo; p = 0.1473; LS Mean Difference -0.3 (95% CI -0.7 to 0.1); NCT03334539 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HL036	Unknown	0.1 %	Topical
Subject	HL036	Unknown	0.25 %	Topical

Indications