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

February 7, 2025 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.05% cyclosporine eyedrops combined with artificial tear eyedrops
Drug: artificial tear eyedrops
The intervention group and control group were treated with artificial tear eyedrops four times a day.
Drug: 0.05% cyclosporine eyedrops
The intervention group was treated twice a day.
Active Comparator: artificial tear eyedrops
Drug: artificial tear eyedrops
The intervention group and control group were treated with artificial tear eyedrops four times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ocular surface disease index (OSDI)
Time Frame: 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.
from baseline to 3 months after treatment
Tear break-up time (TBUT)(s)
Time Frame: 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.
from baseline to 3 months after treatment
Corneal fluorescein staining (CFS)
Time Frame: 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.
from baseline to 3 months after treatment
Schirmer I test (SIt) (mm/5 minutes)
Time Frame: 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.
from baseline to 3 months after treatment
Lissamine green staining
Time Frame: 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.
from baseline to 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the concentration of Interleukin-1β (IL-1β) (pg/ml)
Time Frame: 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.
from baseline to 3 months after treatment
the concentration of Interleukin-6 (IL-6) (pg/ml)
Time Frame: 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.
from baseline to 3 months after treatment
the concentration of Interleukin-10 (IL-10) (pg/ml)
Time Frame: 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.
from baseline to 3 months after treatment
the concentration of Interleukin-17A (IL-17A) (pg/ml)
Time Frame: 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.
from baseline to 3 months after treatment
corneal sensitivity (range, 60-0 mm)
Time Frame: 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.
from baseline to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Hong Qi, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2021

Primary Completion (Actual)

March 4, 2024

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CsA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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