Loading clinical trials...

Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT03226444•TearSolutions, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who meet the following criteria will be selected:
•1. Subjects who are age 18 years of age or older at the time of obtaining informed consent.
•2. Subjects with a documented prior history or current diagnosis of Primary Sjögren's Syndrome according the American-European Consensus Group Sjögren's Syndrome Criteria (Appendix 4; must meet either 4 out of 6 total criteria OR 3 out of 4 signs). Note: Subjects who are on systemic (oral) therapy for the treatment of Sjögren's Syndrome must be on stable systemic treatment defined as the same treatment for the immediately prior 90 days.
•3. Subjects with a history of dry eye-related ocular symptoms, and who have self-reported use of over the counter ocular wetting agents within the last 120 days.
•4. Subjects who meet the following criteria at both screening and Visit 2 (Randomization/Baseline) examinations:
•1. FCS total score ≥ 4 and \< 15 in the NEI/Industry Workshop scale, (Appendix 6)
•2. Symptom Severity score of ≥ 40 using the SANDE questionnaire (Appendix 3)
•3. Anesthetized Schirmer test score ≤ 5 mm wetting/5 min
•4. LGCS total score ≥ 5 using the NEI/Industry Workshop scale (where 0=no staining) Note: Subjects must meet all 4 criteria and eligible scores for FCS, Anesthetized Schirmer and LGCS must be in at least one eye and it must be in the same eye at the time of the visit.

Exclusion Criteria

•Subjects meeting any of the following criteria at the Visit 1 (Screening) or Visit 2 (Randomization/Baseline) visits will be excluded:
•1. Subjects with any active infectious ocular condition.
•2. Subjects who are monocular or have a BCVA, using corrective lenses if necessary, of +1.0 logMAR or worse as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS).
•3. Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis, anterior blepharitis, etc.) not related to dry eye syndrome.
•4. Subjects with clinical evidence of cicatricial ocular surface disease, such as cicatricial ocular pemphigoid or Stevens Johnson syndrome.
•5. Subjects who cannot suspend the use of any topical eye medications (including topical cyclosporine) other than the investigational product during the run-in and the study treatment phase.
•6. Subjects who have used Restasis® (topical ophthalmic cyclosporine) or Xiidra® (topical ophthalmic lifitegrast) within 14 days prior to Visit 1.
•7. Subjects who in the study eye have fluorescein corneal staining (FCS) Total Score = 15 or a Score = 3 in the superior region per the NEI/Industry Workshop scale or subjects who have FCS with diffuse confluent staining, filaments or frank epithelial defects.
•8. Subjects who have active or have had an outbreak of herpetic keratitis within 365 days of Visit 1 or subjects who are on chronic oral antivirals for ocular herpetic disease.
•9. Subjects who cannot suspend the use of and abstain from contact lens use from the Screening Visit (Visit 1) to the end of the study (Visit 5).
+13 more criteria

Locations (35)

University of Alabama Eye Center

Birmingham, Alabama, United States

Doctor My Eyes / Stephen Cohen, OD, PC

Scottsdale, Arizona, United States

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Milton M. Hom, OD FAAO FACAA (Sc)

Azusa, California, United States

University of California, Berkeley, School of Optometry

Berkeley, California, United States

Orange County Ophthalmology

Garden Grove, California, United States

Lugene Eye Institute

Glendale, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Wolstan & Goldberg Eye Associates

Torrance, California, United States

University of Colorado Department of Ophthalmology

Aurora, Colorado, United States

Key Dates

Start Date

June 30, 2017

Primary Completion Date

December 27, 2019

Completion Date

December 27, 2019

Last Updated

January 22, 2020

Enrollment

204

ACTUAL participants

Conditions

Primary Sjögren SyndromeDry Eye

Interventions

0.005% Lacripep

DRUG

0.01% Lacripep

DRUG

Placebo

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITING

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Autologous Serum Eye Drops in Dry Eye Syndrome

Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops