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

NCT05771012 | Completed

• 1 other identifier: 1482
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Management of Punctal Stenosis

Keywords

cyclosporin,; punctal stenosis,; Restasis,; mini-Monoka.

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group A

EXPERIMENTAL

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)

group B

ACTIVE COMPARATOR

patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months.

Device: mini-monoka stent

Interventions

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)

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)

group B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farwaniya Hospital: lead

Study Sites (1)

Farwanyia Hospital

Al Farwānīyah, Farwanyia, 13001, Kuwait

Location

MeSH Terms

Interventions

Cyclosporine; Cyclosporins

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mona Nassief

  Farwaniya Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 16, 2023
• Study Start: January 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

KU (1)