Clinical trial: DRy Eye Outcome and Prescription Study (NCT03652415)

Eligibility criteria:
Inclusion Criteria:

          -  adult patients (18 years and over) with symptoms* of dry eye disease (with or without
             signs, with or without blepharitis) who start one or more artificial tears. *Symptoms
             of dry eye disease include: foreign body sensation, dryness, irritation, itching,
             burning, stinging or grittiness. When signs are present, symptoms of visual
             disturbance such as poor vision and blurred vision are sufficient as a symptom of dry
             eye disease too

          -  must have best corrected visual acuity in at least one eye of at least 6/12.

        Exclusion Criteria:

          -  lacks capacity (e.g. dementia)

          -  poor understanding of English

          -  active other apparent ocular surface disease (including conjunctivitis, abrasion,
             recurrent erosion syndrome, episcleritis, inflamed pingueculum or pterygium, tumour,
             infectious keratitis).

          -  immune ocular pathology (including scleritis and uveitis).

          -  recent (within the last 3 months) or planned ocular surgery or intravitreal
             injections.

          -  current use of other ocular medication, e.g. antiglaucoma drops, g ciclosporine.

          -  use of artificial tears or ointment in the last 1 month.

          -  gross lid abnormalities, including significant ectropion or entropion; facial nerve
             palsy; thyroid eye disease; trichiasis.

        For the qualitative interview study:

        Subject inclusion criteria

        - London NHS Consultant with at least 6 months experience as a Consultant, with a special
        interest in Cornea and External Diseases, Accident and Emergency and Primary Care, or
        General Ophthalmology
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