Effectiveness and Safety of CG-101 Eye Drops in the Treatment of Dry Eye Syndrome
This study is a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of CG-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control.
‣ Patients must meet all the following inclusion criteria to be enrolled in this study:
• Age ≥ 18 years, regardless of gender;
• Clearly understand and voluntarily participate in the study, with the ability and willingness to sign a written informed consent form (ICF) and comply with all study assessments and visits as instructed;
• Male and female participants of childbearing potential must agree to use medically acceptable contraception during the study and for 3 months (90 days) after the study ends. Women who are not postmenopausal or have not been menopausal for less than two years (from the last menstrual period to the signing of the ICF) must have a negative pregnancy test at Visits 0 and 1.
• A history of bilateral dry eye disease prior to the screening visit (i.e., at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision);
• Recent use (within 30 days prior to Visit 0) of artificial tears to relieve dry eye symptoms, with discontinuation of artificial tears at least 72 hours before Visit 0;
• Ocular Surface Disease Index (OSDI) total score ≥ 13 at Visit 0;
• Best corrected visual acuity ≥ 4.3 (5-point recording method on the international standard logarithmic visual acuity chart at 5 meters) in both eyes at Visit 0;
• At least one eye must have a positive corneal fluorescein staining score (CFS) at Visits 0 and 1;
• Non-anesthetic tear secretion test (SIT) ≤ 10 mm/5 min at Visits 0 and 1;
⁃ Tear film break-up time (BUT) ≤ 10 seconds at Visits 0 and 1.