Back to resultsTopical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
Primary Purpose
Management of Punctal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
0.05% cyclosporin (Restasis®, Allergan Inc)
mini-monoka stent
Sponsored by
About this trial
This is an interventional treatment trial for Management of Punctal Stenosis focused on measuring cyclosporin,, punctal stenosis,, Restasis,, mini-Monoka.
Eligibility Criteria
Inclusion Criteria: The study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis Exclusion Criteria: Patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or traumatic causes of punctual or canalicular obstruction, or any other causes of lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal duct obstruction NLDO are excluded from this study.
Sites / Locations
- Farwanyia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months.
patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months.
Outcomes
Primary Outcome Measures
functional success
change in munk score
anatomical success
grading of the punctum by measuring its size in millimeters on slit lamp
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05771012
Brief Title
Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
Official Title
Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (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.
Yes
5. Study Description
Brief Summary
A prospective, controlled, interventional clinical study, includes all patients (16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis. All patients undergo punctal dilatation, canalicular probing and nasolacrimal duct irrigation. Afterwards, patients are divided into two groups: Group A: patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. Group B: patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. Outcome measures are changes in Munk scoring, grading of the punctum, functional and anatomical success. Functional success is defined as Munk score 0 to 1. Anatomical success is defined as grade 3 punctum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Management of Punctal Stenosis
Keywords
cyclosporin,, punctal stenosis,, Restasis,, mini-Monoka.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months.
Intervention Type
Drug
Intervention Name(s)
0.05% cyclosporin (Restasis®, Allergan Inc)
Intervention Description
study the efficacy of topical 0.05% cyclosporin eye drops (Restasis®, Allergan Inc) in management of grade 1 and 2 acquired punctal stenosis (group A)
Intervention Type
Device
Intervention Name(s)
mini-monoka stent
Intervention Description
insertion of mini-monoka stent in the lower punctum in management of grade 1 and 2 acqquired punctal stenosis (group B)
Primary Outcome Measure Information:
Title
functional success
Description
change in munk score
Time Frame
6 months
Title
anatomical success
Description
grading of the punctum by measuring its size in millimeters on slit lamp
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis
Exclusion Criteria:
Patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or traumatic causes of punctual or canalicular obstruction, or any other causes of lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal duct obstruction NLDO are excluded from this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Nassief
Organizational Affiliation
Farwaniya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farwanyia Hospital
City
Al Farwānīyah
State/Province
Farwanyia
ZIP/Postal Code
13001
Country
Kuwait
12. IPD Sharing Statement
Learn more about this trial
Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.
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