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

NCT06981104 | Completed

• 1 other identifier: 2024-0146
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease (DED); Asthenopia

Outcome Measures

Primary Outcomes (3)

• Fluorescent tear film breakup time

  8weeks

• high-frequency component（HFC）

  HFC represents a slight deformation of the lens in a state of relative modulation stillness, indicating tremors in the ciliary muscle

  8weeks

• ASQ-17

  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.

  8weeks

Study Arms (2)

0.05% cyclosporine froup(Group C)

EXPERIMENTAL

Drug: 0.05% cyclosporine eyedrops

0.1% sodium hyaluronate group（Group S）

PLACEBO COMPARATOR

Drug: 0.1% sodium hyaluronate eye drop

Interventions

0.05% cyclosporine eyedrops DRUG

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

0.05% cyclosporine froup(Group C)

0.1% sodium hyaluronate eye drop DRUG

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

0.1% sodium hyaluronate group（Group S）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: November 18, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: November 20, 2025

Record last verified: 2024-11

Locations

CN (1)