Topical Cyclosporine-A for Management of Epiphora (CSA-epiphora)

November 19, 2020 updated by: Mona A Nassief, Farwaniya Hospital

Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis

to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • Farwanyia
      • Kuwait, Farwanyia, Kuwait
        • Farwanyia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients of either sex
  • had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
  • grade 0 punctal stenosis
  • did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.

Exclusion Criteria:

  • congenital punctal obstruction
  • edematous puncti
  • allergic conjunctivitis
  • history of dacryocystitis,
  • inflammatory systemic diseases
  • any previous chemotherapy treatment, and local irradiation.
  • other causes of epiphora, lid laxity, entropion, and ectropion
  • lid malposition, canalicular or nasolacrimal sac or duct obstruction
  • previous eyelid or lacrimal drainage surgery
  • untreated conjunctivitis or blepharitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cyclosporine A
All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.
Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
topical preservative free artificial tears Q.I. D.
Other Names:
  • preservative free artificial tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epiphora grading
Time Frame: 3 months
Munk grading system score from 0 to 5 the higher the worse
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein dye disappearance test (FDT)
Time Frame: 3 months
via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farwaniya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2020

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Farwanyia Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epiphora

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe