Clinical Comparison of Two Daily Disposable Toric Lenses

July 3, 2012 updated by: CIBA VISION
The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Study Type

Interventional

Enrollment (Actual)

240

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign written informed consent.
  • Germany: Be of legal age.
  • Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Wears contact lenses overnight while sleeping.
  • Habitual daily disposable contact lens wearer.
  • Monovision correction during the study.
  • Other protocol-defined 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: nelfilcon A / etafilcon A
Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: nelfilcon A contact lens
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
Other Names:
  • Focus® DAILIES® Toric
Device: etafilcon A contact lens
Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.
Other Names:
  • 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
OTHER: etafilcon A / nelfilcon A
Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: nelfilcon A contact lens
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
Other Names:
  • Focus® DAILIES® Toric
Device: etafilcon A contact lens
Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.
Other Names:
  • 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Vision
Time Frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week, replacing lenses daily
Overall Comfort
Time Frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week, replacing lenses daily
Overall Handling
Time Frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
1 week, replacing lenses daily
Overall Satisfaction
Time Frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week, replacing lenses daily

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Selecting Final Lens Power
Time Frame: Day 0
As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Day 0

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

May 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (ESTIMATE)

June 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-346-C-013

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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