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

NCT03226444 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2020-01-22

No results posted yet for this study

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

Conditions

  • Primary Sjögren Syndrome
  • Dry Eye

Interventions

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.

Sponsors & Collaborators

  • TearSolutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Odrich, MD · TearSolutions, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-12-27
Completion
2019-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226444 on ClinicalTrials.gov