Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses

August 15, 2012 updated by: Alcon Research

Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to Two Marketed Multi-Purpose Solutions for Care of Silicone Hydrogel Soft Contact Lenses

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

233

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04101
        • Portland Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Successful daily wear of Night & Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks.
  • Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (rewetting drops use is also acceptable).
  • Successful lens wear for at least 8 hours per day.
  • Vision correctable to 20/30.
  • Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
  • No corneal surgery within the past 12 months.
  • No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
  • No over-the-counter or prescription ocular medication.
  • No enrollment in another clinical study within 30 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse Events
Safety:
Corneal Fluorescein Staining (Type and Area)
Conjunctival Staining
Lens Deposits
Subject Questions/Subject Likert Questionnaire
Ocular Comfort and Symptom Scales
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Leslie Napier, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 28, 2006

First Submitted That Met QC Criteria

September 28, 2006

First Posted (Estimate)

October 2, 2006

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C-04-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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