A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects with Moderate to Severe Dry Eye Disease

Inclusion Criteria:

1. aged ≥ 18 years old, males or females.

2. Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.

3. Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.

4. Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.

5. Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at leastone region at Visit 1 and Visit 2.

6. Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit

8. Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:

9. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5and <30 corneal fluorescein staining spots on slit lamp microscopy;

10. Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence stainingspots on slit lamp microscopy.

Exclusion Criteria:

1. Subjects with severe dry eye requiring surgical treatment.

2. Systemic use of retinoids within the 12 months prior to Visit 1.

3. Subjects who have had intraocular surgery within 12 months prior to Visit 1 or whorequire intraocular surgery during the study; or subjects who have had eyelidsurgery within 6 months prior to Visit 1.

4. Subjects treated with permanent lacrimal duct embolization; or subjects treated withtemporary lacrimal duct embolization within 6 months prior to Visit 1.

5. Subjects with dry eye correlated with operation；

6. Subjects who had worn corneal contact lens within 3 months prior to Visit 1.

7. Those who have used cyclosporine preparations ocularly or systemically within 1month prior to visit 1.

8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1month prior to visit 1.

9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocularchemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring)or severe conjunctival cup cells destruction (e.g., vitamin A deficiency).

10. Those with significant eyelid margin inflammation or meibomian gland dysfunctionthat, in the opinion of the investigator, may affect the outcome of the trial.