Back to resultsTopical Cyclosporine-A for Management of Epiphora (CSA-epiphora)
Primary Purpose
Epiphora
Status
Completed
Phase
Phase 2
Locations
Kuwait
Study Type
Interventional
Intervention
topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora focused on measuring cyclosporine A, Epiphora, punctal stenosis
Eligibility Criteria
Inclusion Criteria:
- Adult patients of either sex
- had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
- grade 0 punctal stenosis
- did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.
Exclusion Criteria:
- congenital punctal obstruction
- edematous puncti
- allergic conjunctivitis
- history of dacryocystitis,
- inflammatory systemic diseases
- any previous chemotherapy treatment, and local irradiation.
- other causes of epiphora, lid laxity, entropion, and ectropion
- lid malposition, canalicular or nasolacrimal sac or duct obstruction
- previous eyelid or lacrimal drainage surgery
- untreated conjunctivitis or blepharitis
Sites / Locations
- Farwanyia Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyclosporine A
Arm Description
All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.
Outcomes
Primary Outcome Measures
Epiphora grading
Munk grading system score from 0 to 5 the higher the worse
Secondary Outcome Measures
Fluorescein dye disappearance test (FDT)
via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637633
Brief Title
Topical Cyclosporine-A for Management of Epiphora
Acronym
CSA-epiphora
Official Title
Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Farwaniya Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis
Detailed Description
a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora
Keywords
cyclosporine A, Epiphora, punctal stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyclosporine A
Arm Type
Experimental
Arm Description
All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.
Intervention Type
Drug
Intervention Name(s)
topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
Other Intervention Name(s)
preservative free artificial tears
Intervention Description
topical preservative free artificial tears Q.I. D.
Primary Outcome Measure Information:
Title
Epiphora grading
Description
Munk grading system score from 0 to 5 the higher the worse
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fluorescein dye disappearance test (FDT)
Description
via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either sex
had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
grade 0 punctal stenosis
did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.
Exclusion Criteria:
congenital punctal obstruction
edematous puncti
allergic conjunctivitis
history of dacryocystitis,
inflammatory systemic diseases
any previous chemotherapy treatment, and local irradiation.
other causes of epiphora, lid laxity, entropion, and ectropion
lid malposition, canalicular or nasolacrimal sac or duct obstruction
previous eyelid or lacrimal drainage surgery
untreated conjunctivitis or blepharitis
Facility Information:
Facility Name
Farwanyia Hospital
City
Kuwait
State/Province
Farwanyia
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Cyclosporine-A for Management of Epiphora
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