Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Status:
Completed
Trial end date:
2019-08-30
Target enrollment:
Participant gender:
Summary
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular
hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation
PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically
healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability
similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion
criteria:Clinically healthy subjects.