Back to resultsThe Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
artificial tear eyedrops
0.05% cyclosporine eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring dry eye, refractive surgery, 0.05% cyclosporine
Eligibility Criteria
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.
Sites / Locations
- Hong QiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
artificial tear eyedrops
Arm Description
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
artificial tear eyedrops
Outcomes
Primary Outcome Measures
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.
Tear break-up time (TBUT)(s)
BUT is the time from normal blinking to the first appearance of a break in the tear film.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
sub-basal corneal nerve density (mm/mm2)
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.
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.
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)
Full Information
NCT ID
NCT06043908
First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06043908
Brief Title
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
Official Title
The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye, refractive surgery, 0.05% cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
Arm Type
Experimental
Arm Description
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
Arm Title
artificial tear eyedrops
Arm Type
Active Comparator
Arm Description
artificial tear eyedrops
Intervention Type
Drug
Intervention Name(s)
artificial tear eyedrops
Intervention Description
The intervention group and control group were treated with artificial tear eyedrops four times a day.
Intervention Type
Drug
Intervention Name(s)
0.05% cyclosporine eyedrops
Intervention Description
The intervention group was treated twice a day.
Primary Outcome Measure Information:
Title
ocular surface disease index (OSDI)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
Tear break-up time (TBUT)(s)
Description
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Time Frame
from baseline to 3 months after treatment
Title
Corneal fluorescein staining (CFS)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
Schirmer I test (SIt) (mm/5 minutes)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
Lissamine green staining
Description
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.
Time Frame
from baseline to 3 months after treatment
Secondary Outcome Measure Information:
Title
the concentration of Interleukin-1β (IL-1β) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of Interleukin-6 (IL-6) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of Interleukin-10 (IL-10) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of Interleukin-23 (IL-23) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of Interleukin-17A (IL-17A) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of interferon-γ (IFN-γ)(pg/ml)
Description
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
Time Frame
from baseline to 3 months after treatment
Title
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of substance P (SP)(pg/ml)
Description
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of β-endorphin (pg/ml)
Description
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
Time Frame
from baseline to 3 months after treatment
Title
the concentration of neurotensin (pg/ml
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
the concentration of oxytocin(pg/ml)
Description
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay.
Time Frame
from baseline to 3 months after treatment
Title
corneal sensitivity (range, 60-0 mm)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
sub-basal corneal nerve density (mm/mm2)
Description
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.
Time Frame
from baseline to 3 months after treatment
Title
numerical rating scale (NRS)
Description
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.
Time Frame
from baseline to 3 months after treatment
Title
NPSI-Eye (range 0-100 score)
Description
Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
Time Frame
from baseline to 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhao
Phone
13901066889
Ext
010
Email
doctorqihong@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Zhao
Phone
+8619801152870
Ext
010
Email
Drzl1996@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Qi
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Qi
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Qi, M.D.
Phone
13901066889
Email
doctorqihong@163.com
First Name & Middle Initial & Last Name & Degree
Lu Zhao, M.D.
Phone
+8619801152870
Email
Drzl1996@163.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
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