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

P

Peking University

Status and phase

Completed
Phase 4

Conditions

Dry Eye

Treatments

Drug: 0.05% cyclosporine eyedrops
Drug: artificial tear eyedrops

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

0.05% cyclosporine eyedrops combined with artificial tear eyedrops
Experimental group
Treatment:
Drug: artificial tear eyedrops
Drug: 0.05% cyclosporine eyedrops
artificial tear eyedrops
Active Comparator group
Treatment:
Drug: artificial tear eyedrops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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