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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01362907
First received: May 27, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes

May 27, 2011
June 28, 2012
May 2011
June 2011   (final data collection date for primary outcome measure)
  • Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
    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.
  • Overall Comfort [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
    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.
  • Overall Vision Quality [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
    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.
  • Overall Handling [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT01362907 on ClinicalTrials.gov Archive Site
Overall Lens Fit [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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.
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Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
Not Provided

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.
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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
  • Device: Delefilcon A contact lens
    Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
    Other Name: DAILIES® Total1®
  • Device: Etafilcon A contact lens
    Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
    Other Name: 1-DAY ACUVUE® MOIST™
  • Delefilcon A / etafilcon A
    Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
    Interventions:
    • Device: Delefilcon A contact lens
    • Device: Etafilcon A contact lens
  • Etafilcon A / delefilcon A
    Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
    Interventions:
    • Device: Delefilcon A contact lens
    • Device: Etafilcon A contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01362907
P-347-C-013
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP