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

NCT06824844 | Completed Phase 4

• 1 other identifier: CsA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

dry eye; 0.05% cyclosporine; diabetes

Outcome Measures

Primary Outcomes (5)

• ocular surface disease index (OSDI)

  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.

  from baseline to 3 months after treatment

• Tear break-up time (TBUT)(s)

  BUT is the time from normal blinking to the first appearance of a break in the tear film.

  from baseline to 3 months after treatment

• Corneal fluorescein staining (CFS)

  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.

  from baseline to 3 months after treatment

• Schirmer I test (SIt) (mm/5 minutes)

  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.

  from baseline to 3 months after treatment

• Lissamine green staining

  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.

  from baseline to 3 months after treatment

Secondary Outcomes (5)

• corneal sensitivity (range, 60-0 mm)

  from baseline to 3 months after treatment

• the concentration of Interleukin-1β (IL-1β) (pg/ml)

  from baseline to 3 months after treatment

• the concentration of Interleukin-6 (IL-6) (pg/ml)

  from baseline to 3 months after treatment

• the concentration of Interleukin-10 (IL-10) (pg/ml)

  from baseline to 3 months after treatment

• the concentration of Interleukin-17A (IL-17A) (pg/ml)

  from baseline to 3 months after treatment

Study Arms (2)

0.05% cyclosporine eyedrops combined with artificial tear eyedrops

EXPERIMENTAL

Drug: artificial tear eyedrops; Drug: 0.05% cyclosporine eyedrops

artificial tear eyedrops

ACTIVE COMPARATOR

Drug: artificial tear eyedrops

Interventions

artificial tear eyedrops DRUG

The intervention group and control group were treated with artificial tear eyedrops four times a day.

0.05% cyclosporine eyedrops combined with artificial tear eyedrops; artificial tear eyedrops

0.05% cyclosporine eyedrops DRUG

The intervention group was treated twice a day.

0.05% cyclosporine eyedrops combined with artificial tear eyedrops

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hong Qi

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: December 2, 2021
• Primary Completion: March 4, 2024
• Study Completion: June 4, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)