NCT03226444

Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome

A Double-Masked, Randomized, Multi-Center Phase 2 Study to Evaluate the Efficacy and Safety of Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: TearSolutions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of two strengths of Lacripep™ ophthalmic solution versus placebo administered three times daily for four weeks in subjects with a diagnosis of Dry Eye associated with documented Primary Sjögren's Syndrome

Detailed description

This is a multi-center, randomized, placebo-controlled, double-masked, parallel-group study. Subjects will be randomized into three treatment groups: 0.005%, or 0.01% Lacripep™, or placebo in a 1:1:1 ratio.

Conditions

• Primary Sjögren Syndrome
• Dry Eye

Interventions

Type	Name	Description
DRUG	0.005% Lacripep	One drop (approximately 50 microliters) of 0.005% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.
DRUG	0.01% Lacripep	One drop (approximately 50 microliters) of 0.01% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.
DRUG	Placebo	One drop (approximately 50 microliters) of placebo solution will be administered three times a day (TID) to both eyes for four weeks.

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-12-27
• Completion: 2019-12-27
• First posted: 2017-07-21
• Last updated: 2020-01-22

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study