Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Status:
Completed
Trial end date:
2018-03-27
Target enrollment:
Participant gender:
Summary
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free
ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of
ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation
PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically
healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to
comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized,
exploratory.