KeratonjunctivitisNCT04451239
Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis
A study testing topical steroids and cyclosporin-A in people with Keratonjunctivitis, run by Ameera Gamal Abdelhameed at 1 site in Kuwait.
Trial summary
To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in COVID-19 patients with acute keratoconjunctivitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keratonjunctivitis
- What is being tested?
- topical steroids and cyclosporin-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteKuwait
- Study dates
- 30 Jun 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID-19 Patients with keratoconjunctivitis
Who cannot join
- associated ocular pathology or disease
- other causes of keratoconjunctivitis for example allergic or herpetic
Trial locations and contacts
1 site in 1 country.
Kuwait1 site
Farawanyia hospital
Kuwait City, Farawanyia
Mona Nasseif, MD, 96566578919, Monanasseif@gmail.com
About this study
Official title: Combined Topical Corticosteroid and Topical Cyclosporine-A for Management of COVID-19 Keratoconjunctivitis; a Pilot Study
To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in COVID-19 patients with acute keratoconjunctivitis.
Read the 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.
- Conditions
- Keratonjunctivitis
- Being tested
- topical steroids and cyclosporin-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical steroids and cyclosporin-ADrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 keratoconjunctivitis | Other | 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 . Receives: Drug: topical steroids and cyclosporin-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement
eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
Measured: 10-15 days
Signs improvement
conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva
Measured: 10-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratonjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ameera Gamal Abdelhameed
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Responsible party
- Sponsor-investigator, Ameera Gamal Abdelhameed, Mansoura University
- Investigators
- Mona Nasseif, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451239
- Sponsor's protocol ID
- COVID-19 keratoconjunctivitis
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Topical Corticosteroid and Topical Cyclosporine-A for Management of COVID-19 Keratoconjunctivitis; a Pilot Study
- ClinicalTrials.gov ID
- NCT04451239
- Acronym / sponsor ID
- COVID-19 keratoconjunctivitis
- Conditions
- Keratonjunctivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ameera Gamal AbdelhameedUniversity, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 keratoconjunctivitis | Other | Drug: topical steroids and cyclosporin-Acases will receive topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 Patients with keratoconjunctivitis
Key exclusion criteria (2 listed)
- associated ocular pathology or disease
- other causes of keratoconjunctivitis for example allergic or herpetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical steroids and cyclosporin-AAll 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 . | Drug | COVID-19 keratoconjunctivitis |
Primary outcome
Symptom improvement
Time frame: 10-15 days
eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
Signs improvement
Time frame: 10-15 days
conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Nasseif, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical steroids and cyclosporin-A in people with Keratonjunctivitis, run by Ameera Gamal Abdelhameed at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ameera Abdelhameed, MD (01120090000, amiragamal287@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement (time frame: 10-15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.