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

NCT03226444 | Completed Phase 1 FDA Drug

• 1 other identifier: LOS-001
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 35

Brief 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

Keywords

Dry Eye; Primary Sjogren's Syndrome; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Fluorescein Corneal Staining total score

  Mean change from Baseline/Randomization (Visit 2) to Day 28 (Visit 4) in Fluorescein Corneal Staining (FCS) total score \[National Eye Institute (NEI)/Industry Workshop 0-15 scale, 0-3 scale in each of 5 regions\] in the study eye.

  Changes at Week 4 from Baseline

Secondary Outcomes (15)

• Eye Dryness

  Changes at Week 4 from Baseline

• Mean Scores for Individual Symptom Assessments (Reflective)

  Day 28

• Changes in SANDE-1 to Visit 4

  Changes from Baseline to Day 28.

• Mean Scores SANDE 2

  Day 28

• Changes in Individual Symptom Assessments (Instantaneous)

  Changes at Baseline to Day 28

Study Arms (3)

0.005% Lacripep

EXPERIMENTAL

0.005% Lacripep ophthalmic solution

Drug: 0.005% Lacripep

0.01% Lacripep

EXPERIMENTAL

0.01% Lacripep ophthalmic solution

Drug: 0.01% Lacripep

placebo

PLACEBO COMPARATOR

placebo solution

Drug: Placebo

Interventions

0.005% Lacripep DRUG

One drop (approximately 50 microliters) of 0.005% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.

0.005% Lacripep

0.01% Lacripep DRUG

One drop (approximately 50 microliters) of 0.01% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.

0.01% Lacripep

Placebo DRUG

One drop (approximately 50 microliters) of placebo solution will be administered three times a day (TID) to both eyes for four weeks.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet the following criteria will be selected:
• Subjects who are age 18 years of age or older at the time of obtaining informed consent.
• 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.
• 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.
• Subjects who meet the following criteria at both screening and Visit 2 (Randomization/Baseline) examinations:
• FCS total score ≥ 4 and \< 15 in the NEI/Industry Workshop scale, (Appendix 6)
• Symptom Severity score of ≥ 40 using the SANDE questionnaire (Appendix 3)
• Anesthetized Schirmer test score ≤ 5 mm wetting/5 min
• 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.

You may not qualify if:

• Subjects meeting any of the following criteria at the Visit 1 (Screening) or Visit 2 (Randomization/Baseline) visits will be excluded:
• Subjects with any active infectious ocular condition.
• 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).
• Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis, anterior blepharitis, etc.) not related to dry eye syndrome.
• Subjects with clinical evidence of cicatricial ocular surface disease, such as cicatricial ocular pemphigoid or Stevens Johnson syndrome.
• 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.
• Subjects who have used Restasis® (topical ophthalmic cyclosporine) or Xiidra® (topical ophthalmic lifitegrast) within 14 days prior to Visit 1.
• 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.
• 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.
• 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).
• Subjects who have a history of collagen vascular disease, auto immune disease or rheumatic disease other than Primary Sjögren's Syndrome (e.g., Lupus, Rheumatoid Arthritis, etc.).
• Subjects who have a history of or current Anterior Membrane Dystrophy.
• Subjects who have had a corneal transplant or similar corneal surgery (DALK, DSEK, DMEK, etc.).
• Subjects who have used or anticipate use of amiodarone.
• Subjects who within 30 days prior to Visit 1 alter the dose or anticipate alterations to the dose of the following: tetracyclines, Omega 3's or 6's.

Sponsors & Collaborators

• TearSolutions, Inc.: lead

Study Sites (35)

University of Alabama Eye Center

Birmingham, Alabama, 35294, United States

Location

Doctor My Eyes / Stephen Cohen, OD, PC

Scottsdale, Arizona, 85254, United States

Location

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Milton M. Hom, OD FAAO FACAA (Sc)

Azusa, California, 91702, United States

Location

University of California, Berkeley, School of Optometry

Berkeley, California, 94720, United States

Location

Orange County Ophthalmology

Garden Grove, California, 92843, United States

Location

Lugene Eye Institute

Glendale, California, 91204, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

University of Colorado Department of Ophthalmology

Aurora, Colorado, 80045, United States

Location

Corneal Consultants of Colorado

Littleton, Colorado, 80209, United States

Location

Bruce A. Segal, MD PA Private Practice

Delray Beach, Florida, 33484, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

International Eye Associates, PA

Ormond Beach, Florida, 32174, United States

Location

Perez Eye Center

Tampa, Florida, 33603, United States

Location

Eye Consultants of Atlanta

Atlanta, Georgia, 30339, United States

Location

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Location

Midwest Cornea Associates, LLC

Indianapolis, Indiana, 46290, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Clinical Eye Research of Boston

Winchester, Massachusetts, 01890, United States

Location

Minnesota Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Cornea Consultants of Albany

Slingerlands, New York, 12159, United States

Location

Cornerstone Eye Care, PA

High Point, North Carolina, 27262, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Ophthalmic Surgeons & Consultants of Ohio; The Eye Center of Columbus

Columbus, Ohio, 43215, United States

Location

University of Pennsylvania Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

UTHSC Department of Ophthalmology

Memphis, Tennessee, 38163, United States

Location

The Eye Clinic of Texas, an affiliate of Houston Eye Associates

League City, Texas, 77573, United States

Location

University of Virginia University Eye Center

Charlottesville, Virginia, 22903, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Vistar Eye Center

Roanoke, Virginia, 24011, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Odrich, MD

  TearSolutions, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: June 30, 2017
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)