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 range18 Years

SexALL

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;
✕. 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;

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 range18 Years

SexALL

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;
✕. 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;