Skip to main content
OpenTrials
Completed

NCT Number: NCT06824844

The Effect of 0.05% CsA 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Diabetes Mellitus Dry Eye Syndromes Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Lacrimal Apparatus Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: No

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

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.

-

Treatment and study plan

artificial tear eyedrops

Drug

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

0.05% cyclosporine eyedrops

Drug

The intervention group was treated twice a day.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.