Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following phacoemulsification surgery - Trial PACTR202207762785564
Access comprehensive clinical trial information for PACTR202207762785564 through Pure Global AI's free database. This Phase 3 trial is sponsored by Suez Canal University Hospital; Orchidia Pharmaceutical Industries and is currently Recruitment Completed. The study focuses on Eye Diseases.
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Study Focus
drug
Sponsor & Location
Suez Canal University Hospital; Orchidia Pharmaceutical Industries
Moataz A Sallam
Timeline & Enrollment
Phase 3
Aug 01, 2022
Nov 30, 2023
Summary
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 ยฑ 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.
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR202207762785564
Non-Device Trial

