MedTrace Logo

Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®

NCT06375343 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-19

No results posted yet for this study

Summary

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.

Conditions

Interventions

DRUG

PRO-240

-Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.

DRUG

Optive®

\- Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2027-01-30
Completion
2027-01-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375343 on ClinicalTrials.gov