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

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ClinicalTrials.gov Identifier: NCT01362907
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Device: Delefilcon A contact lens Device: Etafilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
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™

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.
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™




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01362907     History of Changes
Other Study ID Numbers: P-347-C-013
First Posted: June 1, 2011    Key Record Dates
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012
Last Verified: June 2012