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

NCT05771012 — Not applicable, Completed, 42 participants, Farwaniya Hospital

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Registry	NCT05771012
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	42 (Actual)
Sponsor	Farwaniya Hospital (Other gov)
Conditions	Management of Punctal Stenosis
Interventions	0.05% cyclosporin (Restasis®, Allergan Inc), mini-monoka stent (Drug, device)
Dates	start 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 in Kuwait

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
group A	Experimental	Drug: 0.05% cyclosporin (Restasis®, Allergan Inc)	patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months.
group B	Active comparator	Device: mini-monoka stent	patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months.

0.05% cyclosporin (Restasis®, Allergan Inc) (Drug): 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)
mini-monoka stent (Device): insertion of mini-monoka stent in the lower punctum in management of grade 1 and 2 acqquired punctal stenosis (group B)

+Outcome measures

Primary outcomes

functional success [6 months]: change in munk score
anatomical success [6 months]: grading of the punctum by measuring its size in millimeters on slit lamp

+Eligibility

Sex: All, ages: 16 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Farwanyia Hospital	Al Farwaniyah, Farwanyia	Kuwait

+Investigators

Mona Nassief, Principal investigator, Farwaniya Hospital

My Notes

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