Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.

Study Overview
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Brief Summary
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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.

Official Title
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Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.

Conditions
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Management of Punctal Stenosis

Intervention / Treatment
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* Drug: 0.05% cyclosporin (Restasis®, Allergan Inc)
* Device: mini-monoka stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. | Drug: 0.05% cyclosporin (Restasis®, Allergan Inc)<br>* 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)<br>|
| Active Comparator: group B<br>patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. | Device: mini-monoka stent<br>* insertion of mini-monoka stent in the lower punctum in management of grade 1 and 2 acqquired punctal stenosis (group B)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional success | change in munk score | 6 months | 
| anatomical success | grading of the punctum by measuring its size in millimeters on slit lamp | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyclosporin,, punctal stenosis,, Restasis,, mini-Monoka.