The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06043908

RS01

Details and patient eligibility

About

The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.

Full description

The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. At the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
• Any gender.
• Provision of written informed consent.

Exclusion criteria

• active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
• Pregnant and lactating women, or those planning a pregnancy over the course of the study.
• Uncontrolled systemic disease.
• 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)

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60 participants in 2 patient groups

0.05% cyclosporine eyedrops combined with artificial tear eyedrops

Experimental group

Description:

0.05% cyclosporine eyedrops combined with artificial tear eyedrops

Treatment:

Drug: artificial tear eyedrops

Drug: 0.05% cyclosporine eyedrops

artificial tear eyedrops

Active Comparator group

Description:

artificial tear eyedrops

Treatment:

Drug: artificial tear eyedrops