Clinical Evaluation of an Investigational Soft Contact Lens

June 26, 2012 updated by: CIBA VISION
The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

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

  • Germany
      • Grosswallstadt, Germany, 63868
        • CIBA VISION Research Clinic
  • United States
    • Georgia
      • Duluth, Georgia, United States, 30097
        • CIBA VISION Research Clinic

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Germany: Be of legal age.
  • USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
  • Sign Informed Consent.
  • Wear soft contact lenses for at least 3 months prior to the study.
  • Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Regularly wear contact lenses on an extended/overnight basis.
  • Germany: pregnant or lactating.
  • 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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Delefilcon A contact lens
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Names:
  • DAILIES TOTAL1®
ACTIVE_COMPARATOR: Lotrafilcon B
Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Names:
  • O2 OPTIX®
  • AIR OPTIX®
ACTIVE_COMPARATOR: Nelfilcon A
Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
Other Names:
  • DAILIES® AquaComfort Plus®
ACTIVE_COMPARATOR: Narafilcon A
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Commercially marketed (Europe) silicone hydrogel, single vision 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 Comfort
Time Frame: 4 weeks
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
4 weeks
Vision Quality During the Day
Time Frame: 4 weeks
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
4 weeks
Overall Handling
Time Frame: 4 weeks
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
4 weeks
Dryness Throughout the Day
Time Frame: 4 weeks
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
4 weeks
Average Daily Wear Time
Time Frame: 4 weeks
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens Fit
Time Frame: 4 weeks
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
4 weeks
Corrected Visual Acuity
Time Frame: 4 weeks
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
4 weeks
Overall Satisfaction
Time Frame: 4 weeks
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
4 weeks

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

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-347-C-003v2s2v2

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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