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Topical Cyclosporine-A for Management of Epiphora

NCT ID: NCT04637633

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2020-11-01

Brief Summary

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

Detailed Description

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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

Conditions

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Epiphora

Keywords

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cyclosporine A Epiphora punctal stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

topical preservative free artificial tears Q.I. D.

Interventions

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

topical preservative free artificial tears Q.I. D.

Intervention Type DRUG

Other Intervention Names

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preservative free artificial tears

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farwaniya Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mona A Nassief

lecturer of ophthalmology Mansoura University Egypt currentlty working as senior registrar in Farwaniya Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Farwanyia Hospital

Kuwait City, Farwanyia, Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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Farwanyia Hospital

Identifier Type: -

Identifier Source: org_study_id