Clinical Trials Logo

Clinical Trial 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®.


Clinical Trial Description

This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include: Primary (safety): - Incidence of unexpected adverse events related to the interventions - Incidence of conjunctival hyperemia and chemosis - Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart - Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale. Primary (tolerability): - Changes in the ocular comfort index (OCI) score Secondary (safety): - Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis). Secondary (tolerability): - Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06363292
Study type Interventional
Source Laboratorios Sophia S.A de C.V.
Contact Alejandra Sanchez-Rios, MD
Phone 33 3001 4200
Email alejandra.sanchez@sophia.com.mx
Status Recruiting
Phase Phase 1
Start date January 30, 2024
Completion date May 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT00565123 - Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis Phase 2/Phase 3
Completed NCT00972777 - Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis Phase 2/Phase 3
Completed NCT00759148 - Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT00798577 - Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment Phase 4
Completed NCT00331916 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT02432807 - Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis Phase 3
Completed NCT01573910 - An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients Phase 3
Terminated NCT01330355 - Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis Phase 3
Completed NCT00332293 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT03004924 - Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo Phase 3
Completed NCT02980523 - Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) Phase 2
Completed NCT01877694 - Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis Phase 2
Completed NCT01175590 - Safety of Besivanceā„¢ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Phase 3
Completed NCT00464438 - A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis Phase 4
Completed NCT00312338 - Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Phase 4
Recruiting NCT03235141 - Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers Phase 1
Completed NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) Phase 3
Completed NCT00105469 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) Phase 3
Withdrawn NCT01238783 - Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis Phase 2
Terminated NCT01740388 - Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Phase 3