Clinical trial: Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome (NCT03319420)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female of any race and ≥ 18 years of age.

          -  Willing and able to provide voluntary written informed consent.

          -  Primary or secondary Sjögren's syndrome according to the American- European Consensus
             Classification Criteria (2002).

          -  Females of childbearing potential must agree to use effective contraception
             consistently throughout the study (such as hormonal contraception or two forms of
             barrier contraception) and have a negative urine pregnancy test at screening.

          -  Willing and able to adhere to the study visit schedule and other protocol
             requirements.

        Exclusion Criteria:

          -  Subject has concurrent, uncontrolled medical condition, or psychiatric illness which
             could place him/her at unacceptable risk.

          -  Subjects with pterygium.

          -  Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious
             origin.

          -  Subjects with blepharitis requiring treatment.

          -  Subjects with a history of surgery affecting the eye surface, as well as eye injuries
             within 3 months of screening.

          -  Subjects currently using any topical ophthalmic treatment (including medications for
             glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
             cannot discontinue these medications for the duration of the trial.

          -  Female subjects who are pregnant or breast-feeding, or plan to become pregnant during
             the study.

          -  Subjects that have started or changed the dose of chronic systemic medication within 7
             days of Visit 1.

          -  Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and
             Carbomer 981) or any of the components in Systane Ultra UD.

          -  Active abuse of alcohol or drugs.

          -  Any condition, which in the opinion of the Investigator, would place the patient at an
             unacceptable risk if participating in the study protocol.
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 95 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? 1