Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

September 28, 2012 updated by: Alcon Research
Three arm study comparing three novel contact lens solutions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Virginia Beach, VA

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:

  • Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
  • Stable correction is defined as longer than six months.
  • Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

  • Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
  • Any systemic or ocular disease that could affect contact lens wear.
  • Women who are pregnant or lactating.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Opti-Free contact lens solution
Device: Opti-Free contact lens solution
Solution
Active Comparator: 2
ReNu Multiplus contact lens solution
Device: ReNu Multiplus contact lens solution
Solution
Active Comparator: 3
Clear Care contact lens solution
Device: Clear Care contact lens solution
Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in corneal fluorescein staining as evaluated at Day 30
Time Frame: 30 Days
30 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Confocal evaluation variables as measured at Days 0, 14, and 30
Time Frame: Day 0, 14, 30
Day 0, 14, 30

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

April 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-08-09

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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