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®.
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)