PACTR202207762785564

Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following phacoemulsification surgery

Evaluation of the Efficacy, safety, and tolerability of Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following uneventful phacoemulsification surgery
Suez Canal University Hospital; Orchidia Pharmaceutical Industries·Phase 3·Pan Africa Clinical Trials Registry·drugRecruitment Completed
Study focus
Disease/Condition
Eye Diseases
Intervention type
drug
Sponsor & location
Primary sponsor
Suez Canal University Hospital; Orchidia Pharmaceutical Industries
Funder
Moataz A Sallam
Location
Egypt
Timeline & enrollment
Phase
Phase 3
Start date
Aug 01, 2022
End date
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 ± 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
Disorders of eyelid in diseases classified elsewhereOther disorders of eyelidOther specified disorders of eyelidInvolvement of eyelid in other diseases classified elsewhereDisorder of eyelid, unspecified
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202207762785564
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.