drugset / Trial / NCT05771012

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

NCT05771012

Completed 42 enrolled Farwaniya Hospital
Non-randomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-01-01
Primary completion
2022-10-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 0.05 % Topical