Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
Abstract
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®.
Conditions: Ophthalmological Agent Toxicity, Bacterial Conjunctivitis.
Primary outcome: Incidence of Unexpected Adverse Events Related to the Interventions; Incidence of Conjunctival Hyperemia; Changes in Best Corrected Visual Acuity (BCVA); Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining); Changes in the Ocular Comfort Index (OCI) Score Between Interventions..
Enrollment: 37 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 37 participants or records.
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