Clinical trial: Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease (NCT04139122)

Eligibility criteria:
Inclusion Criteria:

          -  Body mass index (BMI) within 18.5 to 30.0 kg/m2 (inclusive) and body weight between 45
             kg and 100 kg

          -  Generally healthy as determined by medical history, physical examinations, clinical
             laboratory examination, and ophthalmologic examinations performed at Screening

          -  Have a subject reported history of Dry Eye Disease in both eyes for at least 6 months
             prior to Screening

          -  Non-smoker or ex-smoker for >12 months

        Exclusion Criteria:

          -  Have clinically significant systemic or ophthalmic disease

          -  Has a positive serum pregnancy test at Screening or urine pregnancy test

          -  Have had significant blood loss or have donated or received one or more units (450 mL)
             of blood or plasma within 30 days before randomization

          -  Have used or anticipates use of any prescription or over-the-counter medication,
             including topical medications such as ophthalmic solutions, nasal drops or spray,
             vitamins, alternative and complementary medicines (including herbal formulations)
             within 14 days or 5 half-lives (whichever is longer) before randomization or at any
             time during the study

          -  Use or anticipates use of prescribed dry eye medications within 28 days prior to
             randomization or at any time during the study

          -  Have used or anticipates use CYP3A4 inducers, such as St. John's Wort, within 14 days
             before randomization or at any time during the study.

          -  Have consumed red wine, grapefruit or grapefruit juice, Seville oranges, star fruit,
             or any products containing these items, or any foods that may inhibit CYP3A4, within
             48 hours before randomization and throughout the duration of the study

          -  Have a positive urine alcohol or urine drug test at Screening or Day -1

          -  Contact lens wearers who cannot discontinue the wear over the trial period

          -  Have undergone eye surgery (including laser surgery) within the last 12 months or whom
             the Investigator considers unsuitable

          -  Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye

          -  History of permanent punctal occlusion (cautery or laser) or current use of punctal
             plugs

          -  Any corneal abnormality or disease which might impact normal tear film spreading

          -  Active or history of significant corneal disease

          -  Known allergy or sensitivity to fluorescein, lissamine green or any of the study
             medications

        Other protocol-defined Inclusion/Exclusion Criteria may apply
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? 0