CG-101 Eye Drops in the Treatment of Dry Eye Syndrome

Inclusion Criteria:

Patients must meet all the following inclusion criteria to be enrolled in this study:

1. Age ≥ 18 years, regardless of gender;

2. Clearly understand and voluntarily participate in the study, with the ability andwillingness to sign a written informed consent form (ICF) and comply with all studyassessments and visits as instructed;

3. Male and female participants of childbearing potential must agree to use medicallyacceptable contraception during the study and for 3 months (90 days) after the studyends. Women who are not postmenopausal or have not been menopausal for less than twoyears (from the last menstrual period to the signing of the ICF) must have anegative pregnancy test at Visits 0 and 1.

4. A history of bilateral dry eye disease prior to the screening visit (i.e., at leastone of the following subjective symptoms: ocular dryness, foreign body sensation,burning sensation, fatigue, discomfort, redness, or fluctuating vision);

5. Recent use (within 30 days prior to Visit 0) of artificial tears to relieve dry eyesymptoms, with discontinuation of artificial tears at least 72 hours before Visit 0;

6. Ocular Surface Disease Index (OSDI) total score ≥ 13 at Visit 0;

7. Best corrected visual acuity ≥ 4.3 (5-point recording method on the internationalstandard logarithmic visual acuity chart at 5 meters) in both eyes at Visit 0;

8. At least one eye must have a positive corneal fluorescein staining score (CFS) atVisits 0 and 1;

9. Non-anesthetic tear secretion test (SIT) ≤ 10 mm/5 min at Visits 0 and 1;

10. Tear film break-up time (BUT) ≤ 10 seconds at Visits 0 and 1.

Exclusion Criteria:

• Medical History

1. History of malignant tumors in or around the eyes;

2. Dry eye formed due to scarring (e.g., radiation, alkali burns, Stevens-Johnsonsyndrome, scarring pemphigoid) or destruction of conjunctival goblet cells (e.g., vitamin A deficiency);

3. Active ocular allergy or a history of possible ocular allergy during the studyperiod;

4. Presence of ocular or systemic infection (bacterial, viral, or fungal) atVisits 0 and 1, including fever and herpetic keratitis, or currently receivingantibiotic treatment;

5. History of glaucoma diagnosis;

6. History of any immunodeficiency, HIV infection, hepatitis B or C, acute activehepatitis (anti-HAV IgM positive), organ or bone marrow transplantation;

7. Presence of any significant chronic diseases that the investigator considersmay interfere with study parameters, including but not limited to: severepulmonary diseases, poorly controlled hypertension, and/or poorly controlleddiabetes;

8. Blood donation or significant blood loss (more than 400 ml) within 56 daysbefore Visit 0; Physical or Laboratory Examination Abnormalities

9. Presence of active rosacea-related ocular lesions, periorbital acne, orpterygium in the eyes or eyelids;

10. Anatomical abnormalities of the eyelids (e.g., eyelid laxity, entropion, orectropion) or abnormal blinking patterns;

11. Abnormal findings during slit-lamp and/or fundus examination during thescreening period, which the investigator deems clinically significant (including but not limited to conjunctivitis, trichiasis, conjunctival laxity,glaucoma, uveitis), requiring pharmacological treatment and believed by theinvestigator to potentially interfere with trial results; Previous Medications and Treatments

12. Intraocular surgery or ocular laser surgery, YAG laser capsulotomy, or anysurgery affecting the meibomian glands within the 180 days prior to Visit 0, orplans to undergo such surgery or treatment during the study;

13. Punctal occlusion or surgical removal of plugs (resorbable plugs within 180days) within 60 days before Visit 0, or plans to undergo punctal occlusion orsurgical removal of plugs during the study;

14. Use of systemic immunomodulators, oral doxycycline or tetracycline within 90days before Visit 0, or plans to use these medications irregularly during thestudy;

15. Local use of immunomodulators (e.g., cyclosporine A eye drops, tacrolimus eyedrops) within 30 days before Visit 0;

16. Use of any medications known to cause dryness of the eyes (e.g., diuretics,antidepressants, decongestants, antispasmodics, antihistamines, anesthetics,etc.) within 30 days before Visit 0, or plans to use these medicationsirregularly during the study;

17. Active blepharitis or meibomian gland dysfunction and treatment for the eyes (e.g., eyelid scrubs, meibomian gland massage, wet compresses, hot compresses,systemic antibiotics, and other oral medications for ocular disease) within 30days before Visit 0, or plans to treat irregularly during the study;

18. Use of corticosteroids or mast cell stabilizers (including ocular) within 30days before Visit 0;

19. Use of contact lenses within 14 days before Visit 0, or plans to continue usingthem during the study;

20. Known allergies to test drugs or their excipients, fluorescein, or othersubstances involved in examination; Other

21. Pregnant, nursing, or planning to become pregnant;

22. A family member residing in the same household has already been enrolled inthis study or is a direct relative of staff directly involved in the managementor support of this study;

23. Undergoing a drug or device trial within 30 days or 5 half-lives (whichever islonger) prior to screening, judged by the investigator to potentially affecttrial results, or during the study may necessitate participation in other drugor device trials;

24. Situations that the investigator/sponsor believes may expose participants tosignificant risk, potentially confound trial results, seriously interfere witha participant's ability to participate in the study (e.g., language barriers,illiteracy), or not be in the best interest of the participant.