Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT06363292
Brief 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®.
Detailed 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:
NCT06363292
Study Brief:
Protocol Section:
NCT06363292