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.: PACTR202207762785564 Date of Approval: 11/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following phacoemulsification surgery
Official scientific title Evaluation of the Efficacy, safety, and tolerability of Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following uneventful phacoemulsification surgery
Brief summary describing the background and objectives of the trial Objective: to evaluate the efficacy and safety of difluprednate 0.05% versus prednisolone acetate 1% in patients undergoing phacoemulsification aiming at improving the outcomes in cataract surgery patients and minimizing treatment side effects. Patients and Methods: This randomized comparative controlled clinical trial which will involve patients with senile cataract. All patients will be prone to cataract extraction via phacoemulsification. Postoperatively, patients will be divided into two groups; study group: patients who will take Difluprednate 0.05% eye drops following phacoemulsification and control group: patients who will take prednisolone acetate 1% eye drops following phacoemulsification. All groups will be observed and assessed for two drops effect in managing postoperative inflammation and intraocular pressure. Additionally, tolerability to each drug will be recorded. Statistical analysis: All data will be expressed as means ± standard deviations. Serial changes in outcome measures will be compared using repeated measures analysis of variance. A P value of less than 0.05 is considered statistically significant. Expected outcomes: Difluprednate 0.05% eye drops are better than prednisolone acetate 1% regarding efficacy, safety and tolerability.
Type of trial RCT
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 01/07/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants) 800
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Topical Prednisolone acetate eyedrops QID 14 days Topical eyedrops following cataract extraction by phacoemulsification and intraocular lens implantation 400 Active-Treatment of Control Group
Experimental Group Topical Difluprednate eyedrops QID 14 days Topical Difluprednate 0.05% eyedrops following cataract extraction by phacoemulsification and intraocular lens implantation 400
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age more than 50 years 2. Patients diagnosed to have cataract, LOCS III cataract classification: NO ≥ 2 and NC ≥ 2) 1. Known sensitivity to any of the ingredients in this study medication 2. History of glaucoma or ocular hypertension in the study eye 3. Previous history of steroid-induced increase of intraocular pressure (IOP) 4. Previous ocular surgery 5. history of uveitis 6. Intraoperative complications as posterior capsule rupture 7. Diabetic patients, Pregnancy, Autoimmune patients, and Single eyed patient. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 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 26/06/2022 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Kilo 4.5 Ring road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy, safety and tolerability The first postoperative day and then weekly during the four weeks follow up period
Secondary Outcome Visual acuity The first postoperative day and then weekly during the four weeks follow up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital Kilo 4.5 Ring Road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moataz A Sallam Building no.42 - El-Sheikh Zayed district - Romani theatre Land - 5th stage Ismailia 41112 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospital Kilo 4.5 Ring Road Ismailia 41111 Egypt Hospital
Secondary Sponsor Orchidia Pharmaceutical Industries 110 Al Obour Dalahlia Governorate 33551 Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Amr Abdelfattah Gaballah Kilo 4.5 Ring road Ismailia 41522 Egypt
Ehab Mohamed Moawad Kilo 4.5 Ring road Ismailia 41522 Egypt
Mahmoud Ahmed Ghoneim Kilo 4.5 Ring road Ismailia 41225 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moataz Sallam Moataz.sallam@med.suez.edu.eg +201111113588 Building no.42 - El-Sheikh Zayed district - Romani theatre Land - 5th stage
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Public Enquiries Moataz Sallam moataz.sallam@med.suez.edu.eg +201111113588 Building no.42 - El-Sheikh Zayed district - Romani theatre Land - 5th stage
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Moataz Sallam moataz.sallam@med.suez.edu.eg +201111113588 Building no.42 - El-Sheikh Zayed district - Romani theatre Land - 5th stage
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 18 months The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
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