NCT05771012

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Farwaniya Hospital · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Management of Punctal Stenosis

Interventions

Type	Name	Description
DRUG	0.05% cyclosporin (Restasis®, Allergan Inc)	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)
DEVICE	mini-monoka stent	insertion of mini-monoka stent in the lower punctum in management of grade 1 and 2 acqquired punctal stenosis (group B)

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: Kuwait