CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled
Drug / intervention
PRO-231 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06363292
NCT06363292Phase 1Completed
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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.

Laboratorios Sophia S.A de C.V.·interventional·Posted Apr 12, 2024·Updated Jun 15, 2025

In Brief

A Phase 1 clinical trial evaluating PRO-231 and VIGAMOXI® for Ophthalmological Agent Toxicity and Bacterial Conjunctivitis. Completed, enrolled 37 participants across 1 site.

Detailed Summary

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®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOphthalmological Agent Toxicity, Bacterial Conjunctivitis
CountriesMexico
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedApr 12, 2024
Enrollment StartJan 30, 2024
Primary CompletionMay 28, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.2 years ago

Interventions

PRO-231drug

Moxifloxacin 0.5% Ophthalmic solution.

VIGAMOXI®drug

Moxifloxacin 0.5% Ophthalmic solution.