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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03226444
• Date of registration: 19/07/2017
• Prospective Registration: No
• Primary sponsor: TearSolutions, Inc.
• Public title: Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome
• Scientific 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
• Date of first enrolment: June 30, 2017
• Target sample size: 204
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03226444
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Marc Odrich, MD
• Affiliation: TearSolutions, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren Syndrome

Dry Eye

Intervention(s)

Drug: 0.005% Lacripep

Drug: 0.01% Lacripep

Drug: Placebo

Primary Outcome(s)

Change in Fluorescein Corneal Staining total score [Time Frame: Changes at Week 4 from Baseline]

Secondary Outcome(s)

Changes in Anesthetized Schirmer test [Time Frame: Changes at Week 4 from Baseline]

Changes in SANDE-1 to Visit 4 [Time Frame: Changes from Baseline to Day 28.]

Changes in FCS [Time Frame: Baseline to Day 28]

Changes in Individual Symptom Assessments (Instantaneous) [Time Frame: Changes at Baseline to Day 28]

Mean Scores for SANDE-2 [Time Frame: Visit 5 / Day 42]

Changes in Individual Symptom Assessments (Instantaneous) from Baseline Visit 5 [Time Frame: Baseline to Visit 5]

Mean Scores for six Individual Symptom Assessments (Reflective) [Time Frame: Visit 5 / Day 42]

Changes in FCS at Post-Treatment [Time Frame: Baseline to Visit 5 / Day 42]

Changes in SANDE-1 to Visit 5 [Time Frame: Baseline to Visit 5 / Day 42]

Changes in LGCS [Time Frame: Changes at Week 4 from Baseline]

Changes in Tear Film Break Up Time (TFBUT) [Time Frame: Changes at Week 4 from Baseline]

Mean Scores SANDE 2 [Time Frame: Day 28]

Changes in LCGS Anesthetized Schirmer test, TFBUT [Time Frame: Baseline to Day 28]

Eye Dryness [Time Frame: Changes at Week 4 from Baseline]

Mean Scores for Individual Symptom Assessments (Reflective) [Time Frame: Day 28]

Secondary ID(s)

LOS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors