Dry Eye Disease Clinical Trial
Official title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers
This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.
The variables to be evaluated include: Primary (safety): - Incidence of unexpected advere events (AE's) Secondary: - Changes in the ocular comfort index (OCI) score - Changes in intraocular pressure (IOP) - Changes in Best Corrected Visual Acuity (BCVA) - Adherence to treatment - Changes in tear film breakup time - Changes in fluorescein staining - Changes in lissamine green staining ;
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