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A Clinical Comparison of Two Daily Disposable Contact Lenses.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00775021
First received: October 15, 2008
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Condition Intervention
Myopia
 Device: etafilcon A
Device: nelfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Overall Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Inferior Region Corneal Staining [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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)

  • End of the Day Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.

  • Initial Comfort [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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.

  • Overall Lens Handling [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 123
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775021

Locations
United Kingdom
Otometry Technology Group, Ltd.
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00775021     History of Changes
Other Study ID Numbers: CR-0814, ID08-34
Study First Received: October 15, 2008
Results First Received: February 7, 2011
Last Updated: August 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013