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Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis

Primary Purpose

Keratonjunctivitis

Status
Unknown status
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
topical steroids and cyclosporin-A
Sponsored by
Ameera Gamal Abdelhameed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratonjunctivitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID-19 Patients with keratoconjunctivitis

Exclusion Criteria:

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

Sites / Locations

  • Farawanyia hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 keratoconjunctivitis

Arm Description

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 .

Outcomes

Primary Outcome Measures

Symptom improvement
eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
Signs improvement
conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva

Secondary Outcome Measures

Full Information

First Posted
June 28, 2020
Last Updated
June 28, 2020
Sponsor
Ameera Gamal Abdelhameed
Collaborators
Ministry of Health, Kuwait
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1. Study Identification

Unique Protocol Identification Number
NCT04451239
Brief Title
Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis
Official Title
Combined Topical Corticosteroid and Topical Cyclosporine-A for Management of COVID-19 Keratoconjunctivitis; a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ameera Gamal Abdelhameed
Collaborators
Ministry of Health, Kuwait

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratonjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 keratoconjunctivitis
Arm Type
Other
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
topical steroids and cyclosporin-A
Intervention Description
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 Measure Information:
Title
Symptom improvement
Description
eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
Time Frame
10-15 days
Title
Signs improvement
Description
conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva
Time Frame
10-15 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19 Patients with keratoconjunctivitis Exclusion Criteria: associated ocular pathology or disease other causes of keratoconjunctivitis for example allergic or herpetic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ameera Abdelhameed, MD
Phone
01120090000
Email
amiragamal287@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Nasseif, MD
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farawanyia hospital
City
Kuwait
State/Province
Farawanyia
Country
Kuwait
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Nasseif, MD
Phone
96566578919
Email
Monanasseif@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis

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