Cyclosporine eye gel for moderate to severe dry eye

A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

This will test whether cyclosporine eye gel helps adults with moderate to severe dry eye over 84 days compared with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06766357 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial enrolling about 360 adults with moderate to severe dry eye. Participants are randomized 1:1 to receive cyclosporine ophthalmic gel or a matching vehicle for an 84-day double-blind treatment period, which serves as the main efficacy and safety analysis. After the day‑84 visit, all participants enter an open-label 84-day safety period during which everyone receives the cyclosporine gel. The trial measures both symptoms and objective signs of ocular surface disease to determine benefit and monitor adverse effects.

Who should consider this trial

Good fit: Adults aged 18 or older with at least 6 months of bilateral ocular dryness and objective signs meeting the trial thresholds (EDS ≥40, OSDI ≥13, corneal staining tCFS ≥2, and Schirmer I ≤5 mm/5 min) are ideal candidates.

Not a fit: People whose dry eye is so severe that it requires surgical treatment or who do not meet the required symptom or objective test thresholds are unlikely to benefit from participation in this protocol.

Why it matters

Potential benefit: If successful, the gel could reduce dry eye symptoms and improve ocular surface health for people with moderate to severe disease.

How similar studies have performed: Other topical cyclosporine formulations have shown benefit for dry eye, so this trial builds on established evidence for the drug class.

Eligibility criteria

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

   1. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5 and \<30 corneal fluorescein staining spots on slit lamp microscopy;
   2. Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots 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 who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.
4. Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary 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 1 month prior to visit 1.
8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical 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 dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.

Where this trial is running

Xiamen, Fujian

• Xiamen Eye Center of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Principal investigator: Zuguo Liu — Xiamen Eye Center of Xiamen University
• Study coordinator: Zuguo Liu

Conditions Moderate to Severe Dry Eye