Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
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.
Epistemonikos ID: 67b2f551d6e110a0f9844c45d1aaf97d57a4de9d
First added on: May 21, 2024