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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: artificial tear eyedrops
* Drug: 0.05% cyclosporine eyedrops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>0.05% cyclosporine eyedrops combined with artificial tear eyedrops | Drug: artificial tear eyedrops<br>* The intervention group and control group were treated with artificial tear eyedrops four times a day.<br>Drug: 0.05% cyclosporine eyedrops<br>* The intervention group was treated twice a day.<br>|
| Active Comparator: artificial tear eyedrops<br>artificial tear eyedrops | Drug: artificial tear eyedrops<br>* The intervention group and control group were treated with artificial tear eyedrops four times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concentration of Interleukin-1β (IL-1β) (pg/ml) | 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) | 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) | 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-23 (IL-23) (pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-23 levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of Interleukin-17A (IL-17A) (pg/ml) | 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 | 
| the concentration of tumor necrosis factor-α (TNF-α)(pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. TNF-α levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of interferon-γ (IFN-γ)(pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IFN-γ levels will be quantified by Luminex immunoassay | from baseline to 3 months after treatment | 
| the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. GM-CSF levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of substance P (SP)(pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. α-MSH levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of β-endorphin (pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay | from baseline to 3 months after treatment | 
| the concentration of neurotensin (pg/ml | basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| the concentration of oxytocin(pg/ml) | basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay. | from baseline to 3 months after treatment | 
| corneal sensitivity (range, 60-0 mm) | 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 | 
| sub-basal corneal nerve density (mm/mm2) | Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. | from baseline to 3 months after treatment | 
| numerical rating scale (NRS) | The NRS was used to evaluate ocular pain and consists of a numbered line from 0 to 10 scores that measures pain intensity: 0-1: no pain; 2-4: mild pain; 5-7: moderate pain; and 8-10: severe pain. | from baseline to 3 months after treatment | 
| NPSI-Eye (range 0-100 score) | Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period) | from baseline to 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, refractive surgery, 0.05% cyclosporine