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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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PACTR202207762785564
Phase 3
Recruitment Completed
drug
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202207762785564
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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

Study Focus

Eye Diseases

drug

Sponsor & Location

Suez Canal University Hospital; Orchidia Pharmaceutical Industries

Moataz A Sallam

Egypt

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

Disorders of eyelid in diseases classified elsewhere
Other disorders of eyelid
Other specified disorders of eyelid
Involvement of eyelid in other diseases classified elsewhere
Disorder of eyelid, unspecified

Data Source

Pan Africa Clinical Trials Registry

PACTR202207762785564

Non-Device Trial