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

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ClinicalTrials.gov Identifier: NCT03226444
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
TearSolutions, Inc.

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

Condition or disease Intervention/treatment Phase
Primary Sjögren Syndrome Dry Eye Drug: 0.005% Lacripep Drug: 0.01% Lacripep Drug: Placebo Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-masked
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.005% Lacripep
0.005% Lacripep ophthalmic solution
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.

Experimental: 0.01% Lacripep
0.01% Lacripep ophthalmic solution
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.

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




Primary Outcome Measures :
  1. Change in Fluorescein Corneal Staining total score [ Time Frame: Changes at Week 4 from Baseline ]
    Change in Fluorescein Corneal Staining total score (NEI/Industry Workshop 0-15 scale) in the study eye at Week 4 (Visit 4) from Randomization/Baseline (Visit 2)


Secondary Outcome Measures :
  1. Eye Dryness [ Time Frame: Changes at Week 4 from Baseline ]
    Changes in Eye Dryness (Instantaneous) at Week 4 (Visit 4) from Randomization/Baseline (Visit 2)

  2. Mean Scores SANDE 2 [ Time Frame: Week 4 ]
    Mean Scores for (global scores SANDE-2) at Week 4 (Visit 4).

  3. Changes in Individual Symptom Assessments (Instantaneous) [ Time Frame: Changes at Week 4 from Baseline ]
    Changes in Individual Symptom Assessments (Instantaneous) at Week 4 (Visit 4) from Randomization/Baseline (Visit 2)

  4. Mean Scores for Individual Symptom Assessments (Reflective) [ Time Frame: Week 4 ]
    Mean Scores for Individual Symptom Assessments (Reflective) at Week 4 (Visit 4)

  5. Changes in LGCS [ Time Frame: Changes at Week 4 from Baseline ]
    Changes in LGCS in the study eye at Week 4 (Visit 4) from Randomization/Baseline (Visit 2).

  6. Changes in Anesthetized Schirmer test [ Time Frame: Changes at Week 4 from Baseline ]
    Changes in Anesthetized Schirmer test in the study eye at Week 4 (Visit 4) from Randomization/Baseline (Visit 2).

  7. Changes in Tear Film Break Up Time (TFBUT) [ Time Frame: Changes at Week 4 from Baseline ]
    Changes in Tear Film Break Up Time (TFBUT) in the study eye at Week 4 (Visit 4) from Randomization/Baseline (Visit 2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  10. 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.).
  11. Subjects who have a history of or current Anterior Membrane Dystrophy.
  12. Subjects who have had a corneal transplant or similar corneal surgery (DALK, DSEK, DMEK, etc.).
  13. Subjects who have used or anticipate use of amiodarone.
  14. 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.
  15. Subjects who within 60 days prior to Visit 1 and for the duration of the study alter the dose or anticipate alterations to the dose of the following: anticholinergics, antidepressants, oral contraceptives, isotretinoin, oral systemic corticosteroids, oral systemic immunosuppressive agents.
  16. Subjects who within 30 days prior to Visit 1 and for the duration of the study use topical ocular antihistamines, ocular, inhaled or intranasal corticosteroids, topical or oral mast cell stabilizers, oral antihistamines, topical or nasal vasoconstrictors, topical ocular NSAIDs, topical ocular antibiotics or serum tears.
  17. Subjects who in the study eye have had cauterization of the punctum or alterations to (insertion or removal) punctal plug(s) within the past 14 days prior to Visit 1. Note: If a punctal plug in place at Visit 2 (Randomization/Baseline) and it is dislodged, the plug should be replaced as soon as possible.
  18. Subjects who, in the study eye, have had corneal refractive surgery (LASIK, PRK, RK).
  19. Subjects who in the study eye, have a history of any operative procedure on the ocular surface or eyelids within 365 days prior to Visit 1 or with a history of intraocular surgery within 90 days prior to Visit 1.
  20. Subjects who are pregnant or suspected to be pregnant and subjects who are breastfeeding or intend to breastfeed. Female subjects of childbearing potential are required to have a negative urine pregnancy test at screening, and must agree to use an acceptable method of contraception from the time of signing informed consent until the end of study visit. Medically acceptable contraception methods include intrauterine device; barrier methods such as diaphragm, condom, cap or sponge, used with a spermicide; or hormonal contraception.
  21. Subjects with any physical or mental impairment that would preclude participation and the ability to give informed consent.
  22. Subjects who have participated in a device or Investigational drug study or clinical trial within 30 days of Visit 1. Participation in another during this study is excluded for the duration of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226444


Contacts
Contact: Roslyn Lewis 919-287-3395 roslyn.lewis@lexitas.com

  Show 27 Study Locations
Sponsors and Collaborators
TearSolutions, Inc.
Investigators
Study Director: Marc Odrich, MD TearSolutions, Inc.

Responsible Party: TearSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03226444     History of Changes
Other Study ID Numbers: LOS-001
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TearSolutions, Inc.:
Dry Eye
Primary Sjogren's Syndrome
Sjogren's Syndrome

Additional relevant MeSH terms:
Dry Eye Syndromes
Xerostomia
Mouth Diseases
Syndrome
Keratoconjunctivitis Sicca
Sjogren's Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions