Clinical trial: Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease (NCT02831387)

Eligibility criteria:
Inclusion Criteria:

          1. Provide written informed consent

          2. Male or female subjects aged 18 to 80 years, inclusive

          3. Have a history of dry eye disease (DED) in both eyes

          4. Be on stable regimens of other needed medications

          5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy
             Study (ETDRS)

          6. Have reported symptoms

          7. Have the following signs in at least one eye: Schirmer score without anesthesia of >1
             and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.

          8. Have normal lid anatomy

        Exclusion Criteria:

          1. Have undergone refractive eye surgery in the past 12 months

          2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not
             resulting in exposure or abnormal blinking is allowed)

          3. Have lid irregularities or deformities

          4. Have a history of glaucoma, a history of an elevated lOP within the past year, or an
             lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)

          5. Have any clinically significant, uncontrolled, or unstable medical or surgical
             conditions that could affect his or her ability to participate

          6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct
             obstruction. Removable punctal plugs are allowed if they have been used regularly for
             at least 60 days prior to the screening visit. However, if a plug comes out during the
             study it must be promptly replaced.

          7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye

          8. Are pregnant or breast feeding

          9. Use of any investigational product or device within 28 days prior to the Screening
             Visit or during the 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.
Subject must be at most 80 Years

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? Contradiction