Topical Cyclosporine-A for Management of Epiphora

NCT04637633 | Completed Phase 2 DMC

• 1 other identifier: Farwanyia Hospital
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epiphora

Keywords

cyclosporine A; Epiphora; punctal stenosis

Outcome Measures

Primary Outcomes (1)

• Epiphora grading

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

  3 months

Secondary Outcomes (1)

• Fluorescein dye disappearance test (FDT)

  3 months

Study Arms (1)

Cyclosporine A

EXPERIMENTAL

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,

Interventions

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

topical preservative free artificial tears Q.I. D.

Also known as: preservative free artificial tears

Cyclosporine A

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Farwaniya Hospital: lead

Study Sites (1)

Farwanyia Hospital

Kuwait City, Farwanyia, Kuwait

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ophthalmology Mansoura University Egypt currentlty working as senior registrar in Farwaniya Hospital

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: November 20, 2020
• Study Start: August 15, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 1, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)