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Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04451239
Recruitment Status : Unknown
Verified June 2020 by Ameera Gamal Abdelhameed, Mansoura University.
Recruitment status was:  Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Ministry of Health, Kuwait
Information provided by (Responsible Party):
Ameera Gamal Abdelhameed, Mansoura University

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.

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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

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 .

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • COVID-19 Patients with keratoconjunctivitis

Exclusion Criteria:

  • associated ocular pathology or disease
  • other causes of keratoconjunctivitis for example allergic or herpetic

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 identifier (NCT number): NCT04451239

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Contact: Ameera Abdelhameed, MD 01120090000

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Farawanyia hospital
Kuwait, Farawanyia, Kuwait
Contact: Mona Nasseif, MD    96566578919   
Sponsors and Collaborators
Ameera Gamal Abdelhameed
Ministry of Health, Kuwait
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Principal Investigator: Mona Nasseif, MD Tanta University
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Responsible Party: Ameera Gamal Abdelhameed, Lecturer of Ophthalmology, Mansoura University 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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Conjunctival Diseases
Eye Diseases
Corneal Diseases
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