Topical Cyclosporine-A for Management of Epiphora

Epiphora Clinical Trial

— CSA-epiphora  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637633
• Other study ID #: Farwanyia Hospital
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 15, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Farwaniya Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 1, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiphora
• Lacrimal Apparatus Diseases

Intervention

Drug:
• topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,
topical preservative free artificial tears Q.I. D.

Locations

Country	Name	City	State
Kuwait	Farwanyia Hospital	Kuwait	Farwanyia

Sponsors (1)

Lead Sponsor	Collaborator
Farwaniya Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epiphora grading	Munk grading system score from 0 to 5 the higher the worse	3 months
Secondary	Fluorescein dye disappearance test (FDT)	via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters	3 months