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Completed

NCT Number: NCT06981104

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

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.

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Key information

Conditions

Dry Eye Disease (DED) Asthenopia Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

0.05% cyclosporine eyedrops

Drug

0.05% cyclosporine, one drop each time, twice a day

0.1% sodium hyaluronate eye drop

Drug

0.1% sodium hyaluronate, one drop each time, three times a day

Primary outcomes

  1. Fluorescent tear film breakup time

    Time frame: 8weeks

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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