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OpenTrials
Completed

NCT Number: NCT01254747

Clinical Evaluation of an Investigational Soft Contact Lens

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIBA VISION Research Clinic, Großwallstadt, Germany

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

delefilcon A contact lens

Device

Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Other names: DAILIES TOTAL1®

Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)

Device

Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Other names: O2 OPTIX®, AIR OPTIX®

Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Device

Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use

Other names: DAILIES® AquaComfort Plus®

Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

Device

Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Other names: 1-DAY ACUVUE® TRUEYE™

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
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.

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