The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 21, 2023
September 1, 2023
1.3 years
September 12, 2023
September 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (17)
the concentration of Interleukin-1β (IL-1β) (pg/ml)
from baseline to 3 months after treatment
the concentration of Interleukin-6 (IL-6) (pg/ml)
from baseline to 3 months after treatment
the concentration of Interleukin-10 (IL-10) (pg/ml)
from baseline to 3 months after treatment
the concentration of Interleukin-23 (IL-23) (pg/ml)
from baseline to 3 months after treatment
the concentration of Interleukin-17A (IL-17A) (pg/ml)
from baseline to 3 months after treatment
- +12 more secondary outcomes
Study Arms (2)
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
EXPERIMENTAL0.05% cyclosporine eyedrops combined with artificial tear eyedrops
artificial tear eyedrops
ACTIVE COMPARATORartificial tear eyedrops
Interventions
The intervention group and control group were treated with artificial tear eyedrops four times a day.
The intervention group was treated twice a day.
Eligibility Criteria
You may qualify if:
- Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
- Any gender.
- Provision of written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong Qi
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
Zhao L, Chen J, Duan H, Yang T, Ma B, Zhou Y, Bian L, Cai X, Qi H. Efficacy of topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in post-refractive surgery chronic dry eye patients with ocular pain. BMC Ophthalmol. 2024 Jan 22;24(1):28. doi: 10.1186/s12886-024-03294-z.
PMID: 38247010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Qi
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 21, 2023
Study Start
August 31, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09