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Primary Sjögren SyndromePhase 1/2NCT03226444

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

A Phase 1/2 study testing 0.005% Lacripep and 0.01% Lacripep in people with Primary Sjögren Syndrome and Dry Eye, run by TearSolutions, Inc. at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Sjögren Syndrome, Dry Eye
What is being tested?
0.005% Lacripep and 0.01% Lacripep
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
35 sitesUnited States
Study dates
30 Jun 2017to 27 Dec 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • Subjects who, in the study eye, have had corneal refractive surgery (LASIK, PRK, RK).
  • 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.
  • 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.
  • Subjects with any physical or mental impairment that would preclude participation and the ability to give informed consent.
  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Eye Consultants of Atlanta

    Atlanta, Georgia, 30339

  • University of Colorado Department of Ophthalmology

    Aurora, Colorado, 80045

  • Milton M. Hom, OD FAAO FACAA (Sc)

    Azusa, California, 91702

  • University of California, Berkeley, School of Optometry

    Berkeley, California, 94720

  • University of Alabama Eye Center

    Birmingham, Alabama, 35294

  • Minnesota Eye Consultants, P.A.

    Bloomington, Minnesota, 55431

  • University of Virginia University Eye Center

    Charlottesville, Virginia, 22903

  • Abrams Eye Center

    Cleveland, Ohio, 44115

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

    Columbus, Ohio, 43215

  • Bruce A. Segal, MD PA Private Practice

    Delray Beach, Florida, 33484

  • Bergstrom Eye Research

    Fargo, North Dakota, 58103

  • Orange County Ophthalmology

    Garden Grove, California, 92843

  • Lugene Eye Institute

    Glendale, California, 91204

  • Cornerstone Eye Care, PA

    High Point, North Carolina, 27262

  • Chicago Cornea Consultants, Ltd.

    Hoffman Estates, Illinois, 60169

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana, 46290

  • Bowden Eye & Associates

    Jacksonville, Florida, 32256

  • Tauber Eye Center

    Kansas City, Missouri, 64111

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

    League City, Texas, 77573

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80209

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • UTHSC Department of Ophthalmology

    Memphis, Tennessee, 38163

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • International Eye Associates, PA

    Ormond Beach, Florida, 32174

  • University of Pennsylvania Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701

  • Vistar Eye Center

    Roanoke, Virginia, 24011

  • Doctor My Eyes / Stephen Cohen, OD, PC

    Scottsdale, Arizona, 85254

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

  • Cornea Consultants of Albany

    Slingerlands, New York, 12159

  • Ophthalmology Associates

    St Louis, Missouri, 63131

  • Perez Eye Center

    Tampa, Florida, 33603

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505

  • Clinical Eye Research of Boston

    Winchester, Massachusetts, 01890

Other trials in United States

About this study

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

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

Read the 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.

Being tested
0.005% Lacripep, 0.01% Lacripep, Placebo
Keywords
Dry Eye, Primary Sjogren's Syndrome, Sjogren's Syndrome
Medical subject headings
Dry Eye Syndromes, Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.005% LacripepDrug

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

  • 0.01% LacripepDrug

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

  • PlaceboDrug

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

Study groups in NCT03226444
Study groupRoleWhat they receive
0.005% LacripepExperimental0.005% Lacripep ophthalmic solution
Receives: Drug: 0.005% Lacripep
0.01% LacripepExperimental0.01% Lacripep ophthalmic solution
Receives: Drug: 0.01% Lacripep
placeboPlacebo comparatorplacebo solution
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Changes at Week 4 from Baseline

Secondary outcomes (15)

  1. Eye Dryness

    Mean change from Baseline/Randomization (Visit 2) to Day 28 (Visit 4) in Eye Dryness Score (0-100 VAS scale, OU) from Individual Symptom Assessments (Instantaneous)

    Measured: Changes at Week 4 from Baseline

  2. Mean Scores for Individual Symptom Assessments (Reflective)

    Mean Scores for six Individual Symptom Assessments (Reflective) at Day 28 (Visit 4). The individual reflective symptom assessment is assessed in 6 categories (Eye Dryness, Burning/Stinging, Foreign Body Sensation, Eye Discomfort, Eye Pain and Fluctuating Vision). An anchor in the middle at 50 mm representing their symptom severity at the last visit. The 50 mm scale to the left of the anchor located in the center of the scale will measure worsening symptoms (a negative value) and the 50 mm scale to the right of the anchor located in the center of the scale will measure improving symptoms (a positive value). The lower score represents greater severity.

    Measured: Day 28

  3. Changes in SANDE-1 to Visit 4

    Changes in Symptom Assessment in Dry Eye Questionnaires (SANDE) Version 1 global score from Randomization/Baseline (Visit 2) to Day 28 (Visit 4). SANDE Version 1 questionnaire contains two items measuring the frequency and severity of dry eye symptoms. Each item is assessed on a 100 mm visual analog scale from 0 (Rarely for frequency, Very mild for severity) to 100 mm (All the time for frequency, Very Severe for severity), with higher scores representing greater frequency/severity.

    Measured: Changes from Baseline to Day 28.

  4. Mean Scores SANDE 2

    Mean Scores for Symptom Assessment in Dry Eye Questionnaires (SANDE) Version 2 global scores at day 28 (Visit 4). SANDE Version 2 questionnaire contains two items measuring the frequency and severity of dry eye symptoms.The 50 mm scale to the left of the anchor located in the center of the scale will measure improving symptoms (a negative value) and the 50 mm scale to the right of the anchor located in the center of the scale will measure worsening symptoms (a positive value).

    Measured: Day 28

  5. Changes in Individual Symptom Assessments (Instantaneous)

    Changes in each of the 5 additional Individual Symptom Assessment (Instantaneous) from Randomization/Baseline (Visit 2) to Day 28 (Visit 4). The individual instantaneous symptom assessment is a questionnaire that uses a 0-100 mm visual analog scale to rate the severity of each ocular symptom for both eyes (OU). There are six categories (Eye Dryness, Burning/Stinging, Foreign Body Sensation, Eye Discomfort, Eye Pain and Fluctuating Vision). The higher score represents more severe symptoms.

    Measured: Changes at Baseline to Day 28

  6. Changes in LGCS

    Changes in Lissamine Green Conjunctival Staining (LGCS) from Randomization/Baseline (Visit 2) to Day 28 (Visit 4) in the study eye.

    Measured: Changes at Week 4 from Baseline

  7. Changes in Anesthetized Schirmer test

    Change in Anesthetized Schirmer test from Randomization/Baseline (Visit 2) to Day 28 (Visit 4) in the study eye.

    Measured: Changes at Week 4 from Baseline

  8. Changes in Tear Film Break Up Time (TFBUT)

    Changes in tear film break up time (TFBUT) from Randomization/Baseline (Visit 2) to Day 28 (Visit 4) in the study eye

    Measured: Changes at Week 4 from Baseline

  9. Changes in FCS at Post-Treatment

    Changes in Fluorescein Corneal Staining (FCS) from Randomization/Baseline (Visit 2) to the Post-Treatment Follow-Up Visit (day 42) in the study eye. The FCS assessment will be performed for each of the five sections (Central, Inferior, Superior, Temporal, and Nasal) on both eyes (study eye and fellow eye) using the National Eye Institute (NEI)/Industry Workshop scale. The staining in each of the 5 sections of the cornea is evaluated per the NEI score: Grades of 0, 1, 2, and 3 with higher grades representing greater severity.

    Measured: Baseline to Visit 5 / Day 42

  10. Changes in SANDE-1 to Visit 5

    Changes in Symptom Assessment in Dry Eye Questionnaires (SANDE) Version 1 global score from Randomization/Baseline (Visit 2) to the Post Treatment Follow-up visit (Day 42). SANDE Version 1 questionnaire contains two items measuring the frequency and severity of dry eye symptoms. Each item is assessed on a 100 mm visual analog scale from 0 (Rarely for frequency, Very mild for severity) to 100 mm (All the time for frequency, Very Severe for severity), with higher scores representing greater frequency/severity.

    Measured: Baseline to Visit 5 / Day 42

  11. Changes in Individual Symptom Assessments (Instantaneous) from Baseline Visit 5

    Changes in six Individual Symptoms (Instantaneous) from Randomization/Baseline (Visit 2) to the Post-Treatment Follow-up Visit (Day 42). The individual instantaneous symptom assessment is a questionnaire that uses a 0-100 mm visual analog scale to rate the severity of each ocular symptom. There are six categories (Eye Dryness, Burning/Stinging, Foreign Body Sensation, Eye Discomfort, Eye Pain and Fluctuating Vision). The higher score represents more severe symptoms.

    Measured: Baseline to Visit 5

  12. Mean Scores for SANDE-2

    Mean Scores for Symptom Assessment in Dry Eye Questionnaires (SANDE) Version 2 global score at the Post-Treatment Follow-Up Visit (Day 42). SANDE Version 2 questionnaire contains two items measuring the frequency and severity of dry eye symptoms.The 50 mm scale to the left of the anchor located in the center of the scale will measure improving symptoms (a negative value) and the 50 mm scale to the right of the anchor located in the center of the scale will measure worsening symptoms (a positive value).

    Measured: Visit 5 / Day 42

  13. Mean Scores for six Individual Symptom Assessments (Reflective)

    Mean Scores for six Individual Symptom Assessments (Reflective) at the Post-Treatment Follow-Up Visit (Day 42). The individual reflective symptom assessment is assessed in 6 categories (Eye Dryness, Burning/Stinging, Foreign Body Sensation, Eye Discomfort, Eye Pain and Fluctuating Vision). The 50 mm scale to the left of the anchor located in the center of the scale will measure worsening symptoms (a negative value) and the 50 mm scale to the right of the anchor located in the center of the scale will measure improving symptoms (a positive value).

    Measured: Visit 5 / Day 42

  14. Changes in FCS

    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 qualifying fellow eye.

    Measured: Baseline to Day 28

  15. Changes in LCGS Anesthetized Schirmer test, TFBUT

    Changes in Lissamine Green Conjunctival Staining (LCGS) Anesthetized Schirmer test, tear film break up time (TFBUT) from Randomization/Baseline (Visit 2) to Day 28 (Visit 4) in the qualifying fellow eye.

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start30 Jun 2017
  3. Primary completion27 Dec 2019
  4. Study completion27 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226444
Sponsor's protocol ID
LOS-001
Status last verified
Jan 2020
First submitted
19 Jul 2017
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 0.005% Lacripep and 0.01% Lacripep in people with Primary Sjögren Syndrome and Dry Eye, run by TearSolutions, Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fluorescein Corneal Staining total score (time frame: Changes at Week 4 from Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03226444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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