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Completed

NCT Number: NCT04637633

Topical Cyclosporine-A for Management of Epiphora

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

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Key information

Conditions

Epiphora Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Farwanyia Hospital

Kuwait City, Farwanyia, Kuwait

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,

Drug

topical preservative free artificial tears Q.I. D.

Other names: preservative free artificial tears

Primary outcomes

  1. Epiphora grading

    Time frame: 3 months

    Munk grading system score from 0 to 5 the higher the worse

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Farwaniya Hospital

Other Gov

Registry information

Official study title

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

Acronym: CSA-epiphora

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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