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Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT | Clinical Trials | Clareo Health

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Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

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

NCT06981104•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 years old (including 18 and 75 years old), male or female;
•2. 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.
•3. At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT\<5 seconds; Schirmer I \< 5mm/5min
•4. The subjects themselves signed an informed consent form and voluntarily participated in this study.

Exclusion Criteria

•1. 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;
•2. Those who need to wear contact lenses during treatment;
•3. Acute inflammation, infection, allergy, and trauma of the eyes;
•4. There are obvious scars or keratinization on the eyelid margin;
•5. Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
•6. Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;
•7. Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);
•8. I am currently taking medication that may affect dry eye syndrome.

Locations (1)

1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Key Dates

Start Date

November 18, 2024

Primary Completion Date

February 14, 2025

Completion Date

February 14, 2025

Last Updated

November 20, 2025

Enrollment

ACTUAL participants

Conditions

Dry Eye Disease (DED)Asthenopia

Interventions

0.05% cyclosporine eyedrops

DRUG

0.1% sodium hyaluronate eye drop

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITINGPHASE4

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Effect of Yellow Light AG Mobile Phone Screen on Dry Eye and Asthenopia.

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye