CompletedNot Applicable

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

China60 participantsStarted 2024-11-18

Plain-language 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.

Who can participate

Age range

18 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

. 18-75 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.

Exclusion criteria

. 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;

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.

1This trial used 0.05% cyclosporine eye drops for dry eye patients with a short tear film breakup time — is my tear breakup time short enough that I might be a candidate for this type of treatment, and how would you measure that in my case?
2The trial tracked something called asthenopia, which I understand means eye strain or visual fatigue — could my eye strain symptoms actually be connected to my dry eye, and would a treatment like cyclosporine potentially help both problems?
3Since this trial is listed as 'Phase NA' and has already been completed, what do the results tell us — and are the findings strong enough to influence the treatment you'd recommend for me right now?
4The trial measured a 'high-frequency component' as one of its main outcomes, which sounds like it relates to eye movement or blink patterns — can you explain what that means and whether it matters for understanding how well my tear film is working?
5Are there simpler or more established dry eye treatments I should try before considering cyclosporine, or does my specific situation — particularly if I have a short tear breakup time — make cyclosporine worth discussing sooner?

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

Fluorescent tear film breakup time

Timeframe: 8weeks

high-frequency component（HFC）

Timeframe: 8weeks

ASQ-17

Timeframe: 8weeks

Trial details

NCT IDNCT06981104

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-14

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials

Plain-language summary

Who can participate

Age range

18 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

. 18-75 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.

Exclusion criteria

. 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;