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Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT04451239
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Ministry of Health, Kuwait
Information provided by (Responsible Party):
Ameera Gamal Abdelhameed, Mansoura University

Study Description
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Brief Summary:
To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in COVID-19 patients with acute keratoconjunctivitis.

Condition or disease Intervention/treatment Phase
Keratonjunctivitis Drug: topical steroids and cyclosporin-A Not Applicable

Detailed Description:

COVID-19 patients presenting with acute keratoconjunctivitis will be treated with Topical 1% prednisolone acetate fourTimes daily for 7 days as initial treatment, non-preserved artificial tears four times daily and cyclosporin A 0.5% four times daily .

Twelve patients with COVID-19 Keratoconjunctivitis will be enrolled in this open-label study. Symptoms and findings of the patients before and after treatment were recorded.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Topical Corticosteroid and Topical Cyclosporine-A for Management of COVID-19 Keratoconjunctivitis; a Pilot Study
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
COVID-19 keratoconjunctivitis
cases will receive topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .
 Drug: topical steroids and cyclosporin-A
All patient will be treated with Topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .


Outcome Measures
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Primary Outcome Measures :
  1. Symptom improvement [ Time Frame: 10-15 days ]
    eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling

  2. Signs improvement [ Time Frame: 10-15 days ]
    conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 Patients with keratoconjunctivitis

Exclusion Criteria:

  • associated ocular pathology or disease
  • other causes of keratoconjunctivitis for example allergic or herpetic
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451239


Contacts
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Contact: Ameera Abdelhameed, MD 01120090000 amiragamal287@gmail.com

Locations
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Kuwait
Farawanyia hospital
Kuwait, Farawanyia, Kuwait
Contact: Mona Nasseif, MD    96566578919    Monanasseif@gmail.com   
Sponsors and Collaborators
Ameera Gamal Abdelhameed
Ministry of Health, Kuwait
Investigators
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Principal Investigator: Mona Nasseif, MD Tanta University
More Information
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Responsible Party: Ameera Gamal Abdelhameed, Lecturer of Ophthalmology, Mansoura University
ClinicalTrials.gov Identifier: NCT04451239    
Other Study ID Numbers: COVID-19 keratoconjunctivitis
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors