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

July 25, 2025 updated by: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 360 subjects are planned to be enrolled in this study. This study is divided into two stages. The first stage (double-blind treatment period) is the main efficacy and safety evaluation stage, which lasts for 84 days. During this period, subjects are randomly assigned to receive the experimental drug or control drug in a 1:1 ratio, with the analysis of the first stage as the main analysis. After completing the 84th day visit, the subjects will enter the second stage (open treatment period). The second stage is a safety observation period of 84 days, during which all subjects use the experimental drug.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • Xiamen Eye Center of Xiamen University
        • Principal Investigator:
          • Zuguo Liu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
1 drop each time, once every night at bedtime
Drug: Cyclosporine ophthalmic gel
Administer to eyes
Other Names:
  • Cyclosporine
Placebo Comparator: Control group
1 drop each time, once every night at bedtime
Drug: Cyclosporine ophthalmic gel vehicle
Administer to eyes
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eye Dryness Score(EDS)
Time Frame: 84 days
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 84 (binocular)
84 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eye Dryness Score(EDS)
Time Frame: 14 days and 42 days
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 14 and Day 42 (binocular)
14 days and 42 days
Total VAS score for dry eye symptoms
Time Frame: 14 days, 42 days and 84 days
Mean change from baseline in total VAS score of dry eye symptoms (evaluated on a 0-100 VAS score) on Day 14, Day 42 and Day 84 (binocular)
14 days, 42 days and 84 days
Total corneal fluorescein staining score(tCFS)
Time Frame: 14 days, 42 days and 84 days
The proportion of subjects with a total corneal fluorescein staining score (tCFS, modified NEI scale) of 0 on Day 14, Day 42, and Day 84 (study eye)
14 days, 42 days and 84 days
Schirmer test
Time Frame: 14 days, 42 days and 84 days
The proportion of subjects with a change of ≥ 10mm from baseline in the Schirmer test (tear secretion test) on Day 14, Day 42, and Day 84 (study eye)
14 days, 42 days and 84 days
tear film break-up time(BUT)
Time Frame: 14 days, 42 days and 84 days
Mean change from baseline in tear film break-up time (BUT) measurements on Day 14, Day 42, and Day 84 (study eye)
14 days, 42 days and 84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zuguo Liu, Xiamen Eye Center of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZKO-CSP-CSA-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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