Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis

Sponsor

Ameera Gamal Abdelhameed (Other)

Overall Status

Unknown status

CT.gov ID

NCT04451239

Collaborator

Ministry of Health, Kuwait (Other)

Enrollment

Location

Arm

Anticipated Duration (Days)

365.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 30, 2020

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 .

Arm

Intervention/Treatment

Other: 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

Primary Outcome Measures

Symptom improvement [10-15 days]
eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
Signs improvement [10-15 days]
conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Farawanyia hospital	Kuwait	Farawanyia	Kuwait

Sponsors and Collaborators

Ameera Gamal Abdelhameed
Ministry of Health, Kuwait

Investigators

Principal Investigator: Mona Nasseif, MD, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ameera Gamal Abdelhameed, Lecturer of Ophthalmology, Mansoura University

ClinicalTrials.gov Identifier:

NCT04451239

Other Study ID Numbers:

COVID-19 keratoconjunctivitis

First Posted:

Jun 30, 2020

Last Update Posted:

Jun 30, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratoconjunctivitis

Cyclosporine

Cyclosporins

Study Results

No Results Posted as of Jun 30, 2020