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A Clinical Comparison of Two Daily Disposable Contact Lenses.

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ClinicalTrials.gov Identifier: NCT00775021
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : March 3, 2011
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Condition or disease Intervention/treatment
Myopia Device: etafilcon A Device: nelfilcon A

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: etafilcon A/nelfilcon A
etafilcon A contact lens worn first and nelfilcon A contact lens worn second
Device: etafilcon A
Contact Lens
Device: nelfilcon A
Contact Lens
Active Comparator: nelfilcon A/etafilcon A
nelfilcon A contact lens worn first and etafilcon A contact lens second.
Device: etafilcon A
Contact Lens
Device: nelfilcon A
Contact Lens


Outcome Measures

Primary Outcome Measures :
  1. Overall Comfort [ Time Frame: 1 week ]
    Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.


Secondary Outcome Measures :
  1. Inferior Region Corneal Staining [ Time Frame: 1 week ]
    The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)

  2. End of the Day Comfort [ Time Frame: 1 week ]
    Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

  3. Initial Comfort [ Time Frame: 1 Week ]
    Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

  4. Overall Lens Handling [ Time Frame: 1 week ]
    Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years to 45 years
  • Current daily soft contact lens as habitual optical correction:
  • Refraction:

    • Best sphere (corrected for back vertex distance) -1.00 to -6.00D
    • Cylinder 0.00 to - 0.75D
  • Best spectacle corrected visual acuity of 6/9 or better in each eye
  • Willingness to adhere to the instructions set in the clinical protocol
  • Signature of the subject on the informed consent form

Exclusion Criteria:

  • Systemic or ocular allergies which might interfere with contact lens wear
  • Systemic disease which might interfere with contact lens wear
  • Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
  • Use of medication which might interfere with contact lens wear
  • Active ocular infection
  • Use of ocular medication
  • Significant ocular anomaly
  • Presence of two or more corneal scars in either eye
  • Pregnancy or lactation
  • Any medical condition that might be prejudicial to the study
  • Participated in any other clinical studies in the past month
  • Currently wears monovision
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775021


Locations
United Kingdom
Otometry Technology Group, Ltd.
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00775021     History of Changes
Other Study ID Numbers: CR-0814
ID08-34
First Posted: October 17, 2008    Key Record Dates
Results First Posted: March 3, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015