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OpenTrials
Completed

NCT Number: NCT01362907

Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Completed

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

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

  • Normal eyes with no use of ocular medications.
  • Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
  • Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
  • Visual acuity with study lenses 20/25 or better.
  • Cylinder less than or equal to 0.75 D.
  • Currently wearing daily disposable lenses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Anterior segment infection, inflammation, or abnormality.
  • Any active anterior segment ocular disease that would contraindicate contact lens wear.
  • Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of refractive surgery or irregular cornea.
  • Eye injury within twelve weeks immediately prior to enrollment for this trial.
  • Currently enrolled in any clinical trial.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

delefilcon A contact lens

Device

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

Other names: DAILIES® Total1®

Etafilcon A contact lens

Device

Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear

Other names: 1-DAY ACUVUE® MOIST™

Primary outcomes

  1. Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)

    Time frame: 1 week of wear, replacing lenses daily

    As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.

  2. Overall Comfort

    Time frame: 1 week of wear, 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 evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  3. Overall Vision Quality

    Time frame: 1 week of wear, 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 quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  4. Overall Handling

    Time frame: 1 week of wear, 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 evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

Secondary outcomes

  1. Overall Lens Fit

    Time frame: 1 week of wear, replacing lenses daily

    As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported 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
2011
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2011
Registry last updated
Aug 3, 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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