Trial intelligence / Profile preview

Manzanilla Sophia vs Meticel Ofteno for Eye Soothing

NCT06373653Phase 4

Key facts

Status
Withdrawn
Start
Feb 2025
Primary completion
Feb 2025
Modality
Small Molecules
Conditions
asthenopia
01

Overview

Phase 4, randomised trial of Manzanilla Sophia in asthenopia (2 arms), sponsored by Laboratorios Sophia. Primary endpoint: Analog visual eyestrain test score at Day 8. Planned start Feb 2025; status: withdrawn.

02

Design

2 arms
Study design
Randomized
  • Manzanilla Sophia®

    Matricaria recutita 0.025% QID for 7 days

  • Meticel Ofteno®

    Hypromellose 0.5% QID for 7 days

03

Who it enrols

Adults with eye strain (score >= 3 on 4 questions) willing to comply with visits. Excludes recent contact lens users, pregnant women, and those with history of drug addiction.

04

Endpoints

Primary

  • Analog visual eyestrain test score

Secondary

  • Incidence of unexpected adverse events related to the interventions

  • Incidence of conjunctival hyperemia

  • Incidence of sensation of ocular dryness

  • Incidence of ocular irritation

  • Incidence of sensation of (sleep-crust)

  • Incidence of sensation of comfort with the application

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