Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206480800979 Date of Approval: 28/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Documentation of a safe and effective treatment for chronic itchy eyes
Official scientific title Effectiveness of tacrolimus eye ointment for the management of chronic vernal keratoconjunctivitis
Brief summary describing the background and objectives of the trial Patients with vernal keratoconjunctivitis will be treated with tacrolimus ointment and treatment efficacy will be assessed
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/07/2022
Actual trial start date
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tacrolimus ointment 6 months Topical tacrolimus eye ointment applied to patients with vernal keratoconjunctivitis 25
Control Group Standard treatment 6months Standard anti allergic drugs 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all new and previously untreated cases diagnosed as VKC of varying severity history of contact lens usage coexisting ocular infections past history of ocular surgery history of herpetic eye disease history of systemic immunosuppressive drug use Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 5 Year(s) 35 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2020 Ethics committee of faculty of medicine port said University
Ethics Committee Address
Street address City Postal code Country
23 December street elzohor Port said 42511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement of manifestations of VKC clinically and by AS OCT At base line, after one month, after three months
Secondary Outcome Relief of vernal keratoconjunctivitis In the future
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Damietta ophthalmology hospital Kornish elnile Damietta 34111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Mahmoud Eltagoury El Terra- mosharafa street Damietta 34111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahmoud Eltagoury Street 107 Ras elbar Damietta 34111 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ehab Ghoneim Por foad Port said 42511 Egypt
Waleed abou samra Elgomherya street Mansoura 7650001 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Eltagoury mahmoud.eltagoury@gmail.com +201221881837 Street 107
City Postal code Country Position/Affiliation
Damietta 34111 Egypt Postgraduate candidate
Role Name Email Phone Street address
Scientific Enquiries Faten Elsafy faten.elsafy@gmail.com +201065009991 Street 107
City Postal code Country Position/Affiliation
Damietta 34111 Egypt Dr
Role Name Email Phone Street address
Public Enquiries Faten Helmy Dr.fatfota84@yahoo.com +201280320575 El Terra
City Postal code Country Position/Affiliation
Damietta 34111 Egypt Mrs
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Objectives Methodology Results
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information