Dry Eye Disease (DED)NCT06981104
Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT
A study testing 0.05% cyclosporine eyedrops and 0.1% sodium hyaluronate eye drop in people with Dry Eye Disease (DED) and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, investigators believe that it may also have therapeutic effects in patients with mild to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED), Asthenopia
- What is being tested?
- 0.05% cyclosporine eyedrops and 0.1% sodium hyaluronate eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18-75 years old (including 18 and 75 years old), male or female;
- Meets the diagnostic criteria for dry eye syndrome in China (2020) and is mild dry eye 1) Dry Eye Questionnaire (OSDI) score ≥ 13 points; 2) BUT ≤ 10 seconds or Schirmer I ≤ 5mm/5 minutes 3) Corneal staining positive ≤ 5 points.
- At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT<5 seconds; Schirmer I < 5mm/5min
- The subjects themselves signed an informed consent form and voluntarily participated in this study.
Who cannot join
- Women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period;
- Those who need to wear contact lenses during treatment;
- Acute inflammation, infection, allergy, and trauma of the eyes;
- There are obvious scars or keratinization on the eyelid margin;
- Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
- Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;
- Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);
- I am currently taking medication that may affect dry eye syndrome.
Trial locations and contacts
1 site in 1 country.
China1 site
1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China
Hangzhou, Zhejiang
About this study
Official title: A Randomized, Double-blind, Controlled Clinical Study on the Efficacy and Safety of 0.05% Cyclosporine Eye Drops in the Treatment of Mild to Moderate Dry Eye
At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, investigators believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. In summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.
- Conditions
- Dry Eye Disease (DED), Asthenopia
- Being tested
- 0.05% cyclosporine eyedrops, 0.1% sodium hyaluronate eye drop
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% cyclosporine eyedropsDrug
0.05% cyclosporine, one drop each time, twice a day
0.1% sodium hyaluronate eye dropDrug
0.1% sodium hyaluronate, one drop each time, three times a day
| Study group | Role | What they receive |
|---|---|---|
| 0.05% cyclosporine froup(Group C) | Experimental | Not described Receives: Drug: 0.05% cyclosporine eyedrops |
| 0.1% sodium hyaluronate group（Group S） | Placebo comparator | Not described Receives: Drug: 0.1% sodium hyaluronate eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent tear film breakup time
Measured: 8weeks
high-frequency component（HFC）
HFC represents a slight deformation of the lens in a state of relative modulation stillness, indicating tremors in the ciliary muscle
Measured: 8weeks
ASQ-17
Asthenopia Survey Questionnaire (ASQ)-17,ASQ-17 covers 7 items of eye symptoms, 6 items of visual symptoms and 4 items of systemic and psychological symptoms with a total score of 51 and an optimal cut-off threshold value of 12.5[1].
[1]Lin N, Li XM, Yang MY, Tian L, Li ZH, Mao JL, Zhang JF, Chen J, Lyu F, Deng RZ. Development of a new 17-item Asthenopia Survey Questionnaire using Rasch analysis. Int J Ophthalmol. 2023 Nov 18;16(11):1867-1875. doi: 10.18240/ijo.2023.11.20. PMID: 38028524; PMCID: PMC10626358.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start18 Nov 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981104
- Sponsor's protocol ID
- 2024-0146
- Status last verified
- Nov 2024
- First submitted
- 12 May 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Clinical Study on the Efficacy and Safety of 0.05% Cyclosporine Eye Drops in the Treatment of Mild to Moderate Dry Eye
- ClinicalTrials.gov ID
- NCT06981104
- Acronym / sponsor ID
- 2024-0146
- Conditions
- Dry Eye Disease (DED), Asthenopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 20 May 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.
At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, investigators believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. In summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.
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 |
|---|---|---|
| 0.05% cyclosporine froup(Group C) | Experimental | Drug: 0.05% cyclosporine eyedrops |
| 0.1% sodium hyaluronate group（Group S） | Placebo comparator | Drug: 0.1% sodium hyaluronate eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old (including 18 and 75 years old), male or female;
- Meets the diagnostic criteria for dry eye syndrome in China (2020) and is mild dry eye 1) Dry Eye Questionnaire (OSDI) score ≥ 13 points; 2) BUT ≤ 10 seconds or Schirmer I ≤ 5mm/5 minutes 3) Corneal staining positive ≤ 5 points.
- At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT<5 seconds; Schirmer I < 5mm/5min
- The subjects themselves signed an informed consent form and voluntarily participated in this study.
Key exclusion criteria (8 listed)
- Women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period;
- Those who need to wear contact lenses during treatment;
- Acute inflammation, infection, allergy, and trauma of the eyes;
- There are obvious scars or keratinization on the eyelid margin;
- Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
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 |
|---|---|---|
| 0.05% cyclosporine eyedrops0.05% cyclosporine, one drop each time, twice a day | Drug | 0.05% cyclosporine froup(Group C) |
| 0.1% sodium hyaluronate eye drop0.1% sodium hyaluronate, one drop each time, three times a day | Drug | 0.1% sodium hyaluronate group（Group S） |
Primary outcome
Fluorescent tear film breakup time
Time frame: 8weeks
high-frequency component（HFC）
Time frame: 8weeks
HFC represents a slight deformation of the lens in a state of relative modulation stillness, indicating tremors in the ciliary muscle
ASQ-17
Time frame: 8weeks
Asthenopia Survey Questionnaire (ASQ)-17,ASQ-17 covers 7 items of eye symptoms, 6 items of visual symptoms and 4 items of systemic and psychological symptoms with a total score of 51 and an optimal cut-off threshold value of 12.5[1]. [1]Lin N, Li XM, Yang MY, Tian L, Li ZH, Mao JL, Zhang JF, Chen J, Lyu F, Deng RZ. Development of a new 17-item Asthenopia Survey Questionnaire using Rasch analysis. Int J Ophthalmol. 2023 Nov 18;16(11):1867-1875. doi: 10.18240/ijo.2023.11.20. PMID: 38028524; PMCID: PMC10626358.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.05% cyclosporine eyedrops and 0.1% sodium hyaluronate eye drop in people with Dry Eye Disease (DED) and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Nov 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescent tear film breakup time (time frame: 8weeks). The study lists 3 primary outcomes in all. 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 20 Nov 2025.