Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification

Summary

objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of inflammation and pain after phacoemulsification. Hypothesis: The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory response evaluated by means of cellularity in the anterior chamber, after phacoemulsification. Methodology: Phase III clinical trial, double-blind, controlled, parallel group, multicentre, randomized. Number of patients: 178 subjects divided into 2 groups (89 subjects per group), who will provide an eye for the evaluation of efficacy. Diagnosis and main inclusion criteria: Diagnosis: Postoperative phacoemulsification and foldable intraocular lens placement in a bag.

Timeline

Start

2018-10-04

Primary completion

2019-08-07

Completion

2019-10-22

Publications

• Palacio-Pastrana C, Chavez-Mondragon E, Soto-Gomez A, Suarez-Velasco R, Montes-Salcedo M, Fernandez de Ortega L, Nasser-Nasser L, Baiza-Duran L, Olvera-Montano O, Munoz-Villegas P. Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial. Clin Ophthalmol. 2020 Jun 12;14:1581-1589. doi: 10.2147/OPTH.S254705. eCollection 2020.

Drugs

Indications