Clinical trial: Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome (NCT03226444)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 1