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

September 12, 2023 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
Drug: artificial tear eyedrops
The intervention group and control group were treated with artificial tear eyedrops four times a day.
Drug: 0.05% cyclosporine eyedrops
The intervention group was treated twice a day.
Active Comparator: artificial tear eyedrops
Drug: artificial tear eyedrops
The intervention group and control group were treated with artificial tear eyedrops four times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
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.
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)
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.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
the concentration of Interleukin-23 (IL-23) (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-23 levels will be quantified by Luminex immunoassay.
from baseline to 3 months after treatment
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.
from baseline to 3 months after treatment
the concentration of tumor necrosis factor-α (TNF-α)(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. 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)
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. 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)
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. GM-CSF levels will be quantified by Luminex immunoassay.
from baseline to 3 months after treatment
the concentration of substance P (SP)(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 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)
Time Frame: from baseline to 3 months after treatment
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)
Time Frame: from baseline to 3 months after treatment
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
Time Frame: from baseline to 3 months after treatment
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)
Time Frame: from baseline to 3 months after treatment
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)
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.
from baseline to 3 months after treatment
sub-basal corneal nerve density (mm/mm2)
Time Frame: from baseline to 3 months after treatment
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)
Time Frame: from baseline to 3 months after treatment
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)
Time Frame: from baseline to 3 months after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Hong Qi, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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