Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Summary

The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.

Timeline

Start

2019-03-28

Primary completion

2020-06-11

Completion

2020-06-11

Outcome

Mixed primary results

registry analysis (superiority test); Tavilermide 5% vs Placebo; p = 0.5533; Mean Difference (Net) 1.4 (95% CI -3.2 to 6); ANCOVA NCT03925727 ↗

registry analysis (superiority test); Tavilermide 5% vs Placebo; p = 0.0192; Mean Difference (Net) -0.6 (95% CI -1.1 to -0.1); ANCOVA NCT03925727 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tavilermide	Protein / enzyme biologic	1 %	Topical
Subject	Tavilermide	Protein / enzyme biologic	5 %	Topical

Indications