Moderate to Severe Dry EyePhase 3NCT06766357
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
A Phase 3 study testing Cyclosporine ophthalmic gel in people with Moderate to Severe Dry Eye, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Dry Eye
- What is being tested?
- Cyclosporine ophthalmic gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiamen Eye Center of Xiamen University
Xiamen, Fujian
Zuguo Liu, 13696984489, zuguoliu@xmu.edu.cn
Zuguo Liu
About this study
Official title: 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.
Read the 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.
- Conditions
- Moderate to Severe Dry Eye
- Being tested
- Cyclosporine ophthalmic gel, Cyclosporine ophthalmic gel vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ophthalmic gelDrug
Also called Cyclosporine
Administer to eyes
Cyclosporine ophthalmic gel vehicleDrug
Also called Vehicle
Administer to eyes
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1 drop each time, once every night at bedtime Receives: Drug: Cyclosporine ophthalmic gel |
| Control group | Placebo comparator | 1 drop each time, once every night at bedtime Receives: Drug: Cyclosporine ophthalmic gel vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Dryness Score(EDS)
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 84 (binocular)
Measured: 84 days
Secondary outcomes (5)
Eye Dryness Score(EDS)
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 14 and Day 42 (binocular)
Measured: 14 days and 42 days
Total VAS score for dry eye symptoms
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)
Measured: 14 days, 42 days and 84 days
Total corneal fluorescein staining score(tCFS)
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)
Measured: 14 days, 42 days and 84 days
Schirmer test
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)
Measured: 14 days, 42 days and 84 days
tear film break-up time(BUT)
Mean change from baseline in tear film break-up time (BUT) measurements on Day 14, Day 42, and Day 84 (study eye)
Measured: 14 days, 42 days and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start3 Apr 2025
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuguo Liu, Principal investigator, Xiamen Eye Center of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766357
- Sponsor's protocol ID
- ZKO-CSP-CSA-302
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06766357
- Acronym / sponsor ID
- ZKO-CSP-CSA-302
- Conditions
- Moderate to Severe Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Cyclosporine ophthalmic gel1 drop each time, once every night at bedtime |
| Control group | Placebo comparator | Drug: Cyclosporine ophthalmic gel vehicle1 drop each time, once every night at bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine ophthalmic gelAlso: CyclosporineAdminister to eyes | Drug | Experimental group |
| Cyclosporine ophthalmic gel vehicleAlso: VehicleAdminister to eyes | Drug | Control group |
Primary outcome
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)
5 secondary outcomes
Eye Dryness Score(EDS)
Time frame: 14 days and 42 days
Total VAS score for dry eye symptoms
Time frame: 14 days, 42 days and 84 days
Total corneal fluorescein staining score(tCFS)
Time frame: 14 days, 42 days and 84 days
Schirmer test
Time frame: 14 days, 42 days and 84 days
tear film break-up time(BUT)
Time frame: 14 days, 42 days and 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuguo Liu principal investigator
Xiamen Eye Center of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine ophthalmic gel in people with Moderate to Severe Dry Eye, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuguo Liu (13696984489, zuguoliu@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Dryness Score(EDS) (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.