Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Status:
Not yet recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its
instillation on the ocular surface of healthy volunteers through the following variables:
unexpected adverse events incidence and photophobia (primary outcome variables); as well as
pupillary diameter, expected adverse events incidence, best near corrected visual acuity
(BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and
conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),