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An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

NCT01594294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-07-25

Study results available
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Summary

The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.

Conditions

  • Myopia

Interventions

DEVICE

AOSEPT® Plus contact lens solution

Hydrogen peroxide-based cleaning and disinfection system

DEVICE

ReNu MultiPlus® contact lens solution

Polyaminopropyl biguanide (PHMB) preserved multipurpose solution

DEVICE

Etafilcon A contact lenses

Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.

DEVICE

Lotrafilcon B contact lenses

Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.

DEVICE

COMPLETE® MPS Easy Rub® Formula contact lens solution

PHMB 0.0001% and poloxamer 0.05% multipurpose solution

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Renee Garofalo, OD, FAAO · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

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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 NCT01594294 on ClinicalTrials.gov