Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium

September 28, 2012 updated by: Alcon Research
The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Successful contact lens wear on a daily wear basis
  • Wear contact lenses at least 8 hours/day
  • Vision correctable to at least 20/30
  • Normal Eyes
  • Other protocol-defined inclusion criteria may apply

Exclusion:

  • Topical ocular medication use
  • Other protocol-defined inclusion criteria may apply

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opti Free RepliniSH
Device: OPTI-FREE RepleniSH
Multi-Purpose Solution for soft contact lenses
Active Comparator: ReNu Multi-Plus
Device: ReNu MultiPlus MPS
Multi-Purpose Solution for soft contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confocal microscopy analysis of Corneal Epithelium
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient comfort
Time Frame: 2 weeks
2 weeks
Corneal Staining
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

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

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMA-08-04 / BP-08-01

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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