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: November 21, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014