Clinical Study to Investigate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.

This is an interventional treatment trial for Dry Eye Syndrome Read More

Inclusion Criteria:

1. Age over 19

2. Patient who meets all of the following criteria in at least one of both eyes

   • Fluorescein corneal staining score ≥ 2
   • Schirmer test ≤ 10mm in 5 mins
   • Tear break-up time ≤ 10 secs
3. Patient who diagnosed with dry eye syndrome at the time of screening and who have dry eye symptoms (dryness, discomfort, foreign body sensation, pain, vision fluctuation, etc.)
4. Patient who agrees not to use eye drops other than the rescue drugs provided during the clinical trial period
5. Patient who can understand the clinical trial and voluntarily signs an informed consent

Exclusion Criteria:

1. Clinically significant ophthalmic diseases not caused by dry eye disease (corneal surface disease, abnormal corneal sensitivity, abnormal tear excess, etc.) that may confuse the interpretation of clinical trial results
2. In case of being treated with anti-inflammatory therapy for dry eye, such as steroid or non-steroidal anti-inflammatory eye drops, autologous serum eye drops, etc.
3. In case of administration of steroids or immunosuppressants (azathioprine, tacrolimus, cyclosporine, mofetil mycophenolate, etc.)
4. Patient who has worn contact lenses within 72 hours prior to screening or need to wear contact lenses during the clinical trial period
5. A history of intraocular surgery within 90 days prior to screening
6. Active eye infection symptoms such as anterior uveitis, anterior blepharitis, and Steven-Johnson syndrome
7. Patient with an eye allergy or who are currently receiving treatment for an allergic eye disease (using antihistamines, etc.)
8. Autoimmune disease (ex. Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
9. Patient who needs surgery due to surface elevation caused by Meibomian Gland Dysfunction (MGD)
10. A history of corneal transplantation or neurotrophic keratitis
11. Patient who has an intraocular pressure of 25 mmHg or higher in one or more of both eyes or have been diagnosed with glaucoma
12. Patient who has undergone vision correction surgery such as LASIK (Laser-Assisted in Situ Keratomileusis) within 12 months prior to screening
13. Patient who has undergone silicone lacrimal punctal occlusion or cauterization of the punctum within 90 days prior to screening. However, patient who has undergone collagen lacrimal punctal occlusion can be enrolled.
14. Hypersensitivity to the ingredients of the investigational product including rebamipide
15. Clinically significant liver, kidney, nervous system, immune system, respiratory or endocrine disease, blood/tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or a history of those diseases

16. Patient who shows the following examination findings at visit 1 (screening visit)

    • WBC ≤ 4,000/mm3
    • Platelets ≤ 100,000/mm3
    • AST/ALT/ALP ≥ 3 times the upper limit of normal(ULN)
    • Total bilirubin ≥ 1.5 times the upper limit of normal(ULN)
17. A woman who has a positive Serum hCG test at the screening visit (Visit 1), or who does not agree to use at least one effective contraceptive method that is medically acceptable
18. Take oral contraceptives during the study period
19. Pregnant or lactating women
20. A history of drug or alcohol abuse
21. Participation in an investigational drug or device trial within 30 days prior to screening
22. Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial