The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: artificial tear eyedrops; Drug: 0.05% cyclosporine eyedrops

• Registration Number: NCT06824844
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-02
• Primary Completion: 2024-03-04
• Study Completion: 2024-06-04
• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

I. Age: 50 to 70 years old; II. Gender: No restriction; III. Meets the diagnostic criteria for dry eye: Refer to the 2020 Chinese Expert Consensus on Diagnostic Criteria for Dry Eye.

IV. Meets the diagnostic criteria for diabetes: History of type 2 diabetes with a course of ≥5 years; Diagnosis refers to the 1999 WHO Diagnostic Criteria for Diabetes.

V. Provision of written informed consent.

Exclusion Criteria

I. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.

II. Uncontrolled systemic disease. III.Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.05% cyclosporine eyedrops combined with artificial tear eyedrops	artificial tear eyedrops	-
0.05% cyclosporine eyedrops combined with artificial tear eyedrops	0.05% cyclosporine eyedrops	-
artificial tear eyedrops	artificial tear eyedrops	-

Primary Outcome Measures

Name	Time	Method
ocular surface disease index (OSDI)	from baseline to 3 months after treatment	OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Tear break-up time (TBUT)(s)	from baseline to 3 months after treatment	BUT is the time from normal blinking to the first appearance of a break in the tear film.
Corneal fluorescein staining (CFS)	from baseline to 3 months after treatment	The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15.
Schirmer I test (SIt) (mm/5 minutes)	from baseline to 3 months after treatment	The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
Lissamine green staining	from baseline to 3 months after treatment	To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.

Secondary Outcome Measures

Name	Time	Method
corneal sensitivity (range, 60-0 mm)	from baseline to 3 months after treatment	Corneal sensitivity will be measured in the right eye only using the Cochet-Bonnet aesthesiometer and the ascending method of limits to determine the threshold of stimulus detection.
the concentration of Interleukin-1β (IL-1β) (pg/ml)	from baseline to 3 months after treatment	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-1β levels will be quantified by Luminex immunoassay.
the concentration of Interleukin-6 (IL-6) (pg/ml)	from baseline to 3 months after treatment	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-6 levels will be quantified by Luminex immunoassay.
the concentration of Interleukin-10 (IL-10) (pg/ml)	from baseline to 3 months after treatment	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-10 levels will be quantified by Luminex immunoassay.
the concentration of Interleukin-17A (IL-17A) (pg/ml)	from baseline to 3 months after treatment	basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-17A levels will be quantified by Luminex immunoassay.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Beijing, China