Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification
Status:
Completed
Trial end date:
2019-10-22
Target enrollment:
Participant gender:
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.