Clinical trial: Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease (NCT04679883)

Eligibility criteria:
Inclusion Criteria:

          -  Subject who is the age of older than 19 years at the screeing visit

          -  Subject who has symptom at least one or more as below for six months(Irritation,
             foreign body sensation, burning, mucus discharge, blurring, itching, photophobia,
             tired or heavy feeling and pain)

          -  Subject with dry eye syndrome who meet all of the following criteria among the left
             and/or right eyes at the time of screening and baseline visit.

               1. Over six grade as fluorescein corneal staining by National Eye Institute scale

               2. Schirmer I test ≤ 10 mm/5 min.

               3. TFBUT ≤ 6 seconds

          -  At the screening and baseline visit, the intraocular pressure(IOP) of both eyes is
             more than 5 mmHg and below 22 mmHg

          -  At the screening and baseline visit, biocular best corrected visual acuity(BCVA) are
             over 0.2(=+0.7 logMAR or Snellen 20/100)

          -  At the baseline visit, over 80% administration compliance during run-in period as
             placebo in single blind

          -  Subject who signed and dated the informed consent form after understanding fully to
             hear a detailed explanation in the clinical trial

        Exclusion Criteria:

          -  Ophthalmic diseases that may confuse the interpretation of clinical trial results,
             such as clinically significant corneal surface disease, abnormal corneal sensitivity,
             and abnormal tearing

          -  Subject with wounds caused by refractive surgery such as LASIK surgery (However, if it
             does not affect the clinical trial compliance and result evaluation according to the
             investigator's judgment, participation is possible.)

          -  Subject with the following concomitant diseses at screening visit.

               1. Eyelid disease (blepharopathy, blepharolysis, valgus, varus valgus, etc.),
                  conjunctival relaxation, cataracts, and eye diseases requiring treatment

               2. Sjogren's syndrome and secondary Sjogren's syndrome (rheumatoid arthritis,
                  systemic lupus erythematosus, etc.)

               3. Diabetes not controlled despite appropriate treatment (hemoglobin A1c (HbA1c)>
                  9%)

               4. Subject with the following systemic diseases that are not controlled High blood
                  pressure that is not controlled despite administration of antihypertensive drugs
                  (systolic blood pressure (SBP)/diastolic blood pressure (DBP)>160/100 mmHg)
                  Clinically significant cardiopulmonary disease despite appropriate treatment

               5. Acute active hepatitis A, active hepatitis B or C

          -  Subject with the following medical history (including surgical history) at screening
             visit

               1. Organ transplant or bone marrow transplant

               2. History of known immunodeficiency disease or human immunodeficiency virus (HIV)
                  infection

               3. Ophthalmic surgery within 1 year before screening (including LASIK/LASEK surgery)

               4. Subject who has undergone punctal occlusion and have not passed 12 weeks from the
                  time point below.

        After punctal cauterization using electrocautery. After inserting a permanent,
        semi-permanent punctal plug. If a temporary punctal plug is inserted, remove the punctal
        plug.

          -  Subject who has administered the following drugs before the clinical trial or who need
             to be administered during the clinical trial.

               1. Cyclosporine eye drops within 6 weeks before screening

               2. Ophthalmic solutions or antibiotics due to blepharitis, meibomian gland disease,
                  herpes zoster, and eye infection within 6 weeks before screening

               3. Drugs that cause dry eye within 6 weeks before screening (anticholinergics,
                  isotretinoin, etc.)

               4. Oral aspirin or drugs containing aspirin within 6 weeks before screening

               5. Contains corticosteroids, mast cell stabilizers, antihistamines,
                  anti-inflammatory drugs (NSAIDs, etc.), gamma linolenic acid, or omega-3 fatty
                  acids within 6 weeks before screening

               6. Other ophthalmic solutions within 3 days before screening

          -  Subject who wears contact lenses within 1 week before screening or who needs to wear
             them during the clinical trial

          -  Subject with alcoholism or drug abuse history within 1 year before screening

          -  Pregnant women, lactating women, and those who disagree with appropriate contraception
             during the clinical trial (visit 1 to visit 6)

          -  Subject with hypersensitivity to investigator's drugs or their excipients

          -  Subject who participated in other clinical trials within 4 weeks before screening and
             received/received investigator's drug or clinical trial medical devices

          -  Subject judged by other investigators to be inappropriate to participate in this
             clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 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? Contradiction