This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.
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Incidence of Unexpected Adverse Events Related to the Interventions
Timeframe: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Incidence of Conjunctival Hyperemia
Timeframe: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Changes in Best Corrected Visual Acuity (BCVA)
Timeframe: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Timeframe: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
Timeframe: Days 0 (Basal Visit), and 8 (Final Visit)