UnknownNot Applicable

Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye

China100 participantsStarted 2021-12-01

Plain-language summary

To explore the law of changes in ocular surface inflammation when 0.05% cyclosporine eye drops (II) is used to treat dry eye, 50 cases of mild to moderate dry eyes were included. The expectation is finding out whether cyclosporine has a regulatory effect on conjunctival microvascular parameters and other inflammation indicators after cyclosporine eye drops treat dry eye, and analyze the value of conjunctival microvascular indicators in dry eye immunosuppressive therapy.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-65 years old; * meet the 2-3 grade dry eye diagnosis: 1) At least one eye has one or more ocular discomfort symptoms and OSDI score ≥23; 2) At least one eye meets one of the following two: 2 mm/5min≤Schirmer I test (no anesthesia) \<10 mm/5min; BUT≤10s. 3) Corneal spotting but no extensive erosion. Exclusion Criteria: * Contact lens wearers; * Allergies to the study drug; * Active eye infections; history of serious systemic diseases; * Pregnancy or breastfeeding; * Receiving or starting other treatments that may interfere with the interpretation of the results; * Participating any other clinical trials within 3 months; * Previous eye surgery, including laser treatment and refractive surgery; * Need or have undergone punctal embolization or nasolacrimal duct obstruction; * KCS secondary to the destruction of conjunctival goblet cells (such as vitamin A deficiency) ; * Scar formation (such as cicatricial pemphigus, alkali burn, trachoma or radiation).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Conjunctival microvascular blood flow velocity

Timeframe: 12 weeks after commencement of treatment-16 weeks after commencement of treatment

Trial details

NCT IDNCT05131152

SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07

Contact for this trial

Yuqing Deng, MD

18120557291 15927646647@163.com

View on ClinicalTrials.gov More Dry Eye trials