Study population
malignancy, entropion, drug abuse, dryness, blurred vision, ectropion, blepharitis, keratoconus, pterygium, punctal occlusion, LASEK, gastritis, lacrimal gland agenesis, dry eye syndrome, cicatricial keratoconjunctivitis, ocular infections, LASIK, gastrointestinal disturbances, pain, allergic ophthalmologic diseases.5, conjunctival scars, glaucoma
HYPERSENSITIVITY REACTIONS, OCULAR INFECTIONS, RECURRENCE, GASTRITIS, PINGUECULA, ANTERIOR UVEITIS, ECTROPION, EYE, ENTROPION, BLEPHARITIS, GLAUCOMA, KERATOCONUS, DRY EYE SYNDROME, PTERYGIUM, DISEASES, HERPES SIMPLEX KERATITIS, INTRAOCULAR PRESSURE, BLEPHAROSPASM
Patients aged 19 years or older, presenting with symptoms (e.g., foreign body sensation, dryness, glare, pain and blurred vision) suggestive of dry eye syndrome for ≥ 6 months before screening, and meeting the following criteria in one of both eyes at screening or randomization: corneal fluorescein staining score ≥ 4 points according to the National Eye Institute/Industry (NEI) scale and tear volume measured with Schirmer 1 test without anesthesia is ≤ 10 mm/5min (if Schirmer 1 test is 0 mm/5 min, then the result of Schirmer test with nasal stimulation should be ≥ 3 mm/5 min), and patients with best-corrected visual acuity (BCVA) of 20/100 or greater in the both eyes at both screening and randomization visits were included. Exclusion criteria for the current study are summarized in Table 
Exclusion criteria for the randomized controlled trial1. Patients for whom rebamipide therapy is expected to induce the onset of gastrointestinal disturbances or gastritis during the study.2. Patients with a history of systemic steroid or immunosuppressant use within 90 days of the screening visit.3. Patients with a history of using a punctal plug or undergoing ophthalmological surgeries, including punctal occlusion surgery, within 90 days of the screening visit.4. Patients with clinically notable ophthalmologic diseases, other than DES, that may affect the results of the current study such as:- Those with a history of corneal transplantation.- Those with a history of conjunctival scars due to cicatricial keratoconjunctivitis, herpes simplex keratitis, pterygium, pinguecula, congenital lacrimal gland agenesis, keratoconus, neurotrophic keratitis, or Sjogren’s syndrome.- Those with end-stage lacrimal gland disease (Schirmer’s test with nasal stimulation < 3 mm/5 min).- Those with blepharospasm, entropion, ectropion, or eyelash abnormalities.- Patients who need appropriate treatments for active ocular infections (e.g., anterior uveitis, blepharitis, or keratoconjunctivitis).- Patients who are being treated for allergic ophthalmologic diseases.5. Patients with a history of laser vision correction surgeries, such as laser-assisted in situ keratomileusis (LASIK) or laser-assisted subepithelial keratectomy (LASEK), within 12 months of teh screening visit.6. Patients with intraocular pressure (IOP) > 21 mmHg or those who are currently receiving pharmacological treatments for glaucoma at the screening visit.7. Patients with hypersensitivity reactions to rebamipide, an active constituent of the study treatment.8. Patients who plan to wear contact lenses during the study.9. Patients meeting one of the following criteria at screening:- Those with serum creatinine level ≥2× the upper limit of normal (ULN)- Those with serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels ≥2×ULN.10. Patients with a history of malignancy, other than those with no recurrence within 5 years postoperatively.11. Patients receiving treatment, after a diagnosis of alcohol or drug abuse within 1 year of screening.12. Fertile women who did not agree to use medically approved methods of contraception, such as intrauterine device, intrauterine system, tubal ligation or double barrier contraception (a compound use of male condom, female condom, cervical cap, diaphragm or contraceptive sponge), during the study.13. Women who are pregnant or breastfeeding14. Patients with a history of using other drugs or devices in clinical trials within 30 days of study participation.15. Patients who are deemed ineligible for study participation according to the investigator’s judgment