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

NCT06766357 | Recruiting Phase 3

• 1 other identifier: ZKO-CSP-CSA-302
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.

Conditions

Moderate to Severe Dry Eye

Outcome Measures

Primary Outcomes (1)

• Eye Dryness Score(EDS)

  Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 84 (binocular)

  84 days

Secondary Outcomes (5)

• Eye Dryness Score(EDS)

  14 days and 42 days

• Total VAS score for dry eye symptoms

  14 days, 42 days and 84 days

• Total corneal fluorescein staining score(tCFS)

  14 days, 42 days and 84 days

• Schirmer test

  14 days, 42 days and 84 days

• tear film break-up time(BUT)

  14 days, 42 days and 84 days

Study Arms (2)

Experimental group

EXPERIMENTAL

1 drop each time, once every night at bedtime

Drug: Cyclosporine ophthalmic gel

Control group

PLACEBO COMPARATOR

1 drop each time, once every night at bedtime

Drug: Cyclosporine ophthalmic gel vehicle

Interventions

Cyclosporine ophthalmic gel DRUG

Administer to eyes

Also known as: Cyclosporine

Experimental group

Cyclosporine ophthalmic gel vehicle DRUG

Administer to eyes

Also known as: Vehicle

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 18 years old, males or females.
• Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.
• Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
• Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
• Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
• Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit 2.
• Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:
• 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;
• Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots on slit lamp microscopy.

You may not qualify if:

• Subjects with severe dry eye requiring surgical treatment.
• Systemic use of retinoids within the 12 months prior to Visit 1.
• 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.
• Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
• Subjects with dry eye correlated with operation；
• Subjects who had worn corneal contact lens within 3 months prior to Visit 1.
• Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.
• Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
• 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).
• Those with significant eyelid margin inflammation or meibomian gland dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Zuguo Liu

  Xiamen Eye Center of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuguo Liu

CONTACT

13696984489; zuguoliu@xmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: April 3, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)