Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

June 26, 2012 updated by: CIBA VISION
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

Inclusion Criteria:

  • Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
  • Able to wear study lenses in the available powers from -1.00D to -6.00D.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury within twelve weeks of enrollment.
  • History of corneal or refractive surgery.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
  • Monovision correction during the study.
  • Other protocol-defined inclusion/exclusion 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Names:
  • DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Names:
  • 1-DAY ACUVUE TruEye
Other: Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Names:
  • DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Names:
  • 1-DAY ACUVUE TruEye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Vision Quality
Time Frame: 1 week of wear
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear

Collaborators and Investigators

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

Sponsor

CIBA VISION

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, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-337-C-034

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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