Skip to main content
OpenTrials
Completed

NCT Number: NCT01254760

Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Eye Diseases Myopia Refractive Errors

Age range

41 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 41 to 68 (inclusive).
  • Spectacle add between +0.75 and +2.75D (inclusive).
  • Habitual spectacle prescription ≤ 1.00DC (cyl).
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in a clinical trial.
  • Prior refractive surgery.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nelfilcon A multifocal contact lens, investigational

Device

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Nelfilcon A multifocal contact lens, commercial

Device

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Other names: Focus® DAILIES® Progressive

Primary outcomes

  1. End of Day Comfort

    Time frame: 5 days of wear, lenses replaced daily

    End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  2. End of Day Dryness

    Time frame: 5 days of wear, lenses replaced daily

    End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  3. Handling at Removal

    Time frame: 5 days of wear, lenses replaced daily

    Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.

  4. Overall Vision

    Time frame: 5 days of wear, lenses replaced daily

    Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary outcomes

  1. Overall Fit

    Time frame: Day 5, lenses replaced daily

    Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.