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Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

NCT01912768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2015-07-09

Study results available
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Summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Conditions

  • Myopia
  • Astigmatism
  • Hyperopia
  • Refractive Error

Interventions

DEVICE

FID 120947A contact lens disinfecting solution

Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

DEVICE

renu fresh multi-purpose solution

Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses

DEVICE

Soft contact lenses

Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Monica Studzinski, Lead CSM · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2014-05-31

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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 NCT01912768 on ClinicalTrials.gov