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Dispensing Evaluation of a New Galyfilcon A Prototype and Biofinity® Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01180985
First received: August 11, 2010
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to compare the visual acuity and the limbal and bulbar redness of the new galyfilcon A prototype lenses against Biofinity® lenses when worn as daily wear for seven (7) days.


Condition Intervention
Myopia
 Device: galyfilcon A prototype
Device: comfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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:
  • Visual acuity assessment [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
    Visual acuity assessed by the eye doctor using an eye chart.

  • Subject reported comfort [ Time Frame: after 6-8 days lof ens wear ] [ Designated as safety issue: No ]
    Subject reported comfort using a survey.

  • Subject reported vision [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
    Subject reported vision using a survey.


Secondary Outcome Measures:
  • Limbal redness assessment [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
    Eye doctor assessment of limbal redness using a slit lamp.

  • Bulbar redness assessment [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
    Eye doctor assessment of bulbar redness using a slit lamp.

  • Post lens fitting comfort assessment [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
    Subject reported comfort, using a survey, after the eye doctor fit the subject with lenses.


Enrollment: 53
Study Start Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: galyfilcon A/comfilcon A
galyfilcon A prototype contact lenses worn first and comfilcon A contact lenses worn second.
 Device: galyfilcon A prototype
silicone hydrogel contact lens
Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens
Active Comparator: comfilcon A/galyfilcon A
comfilcon A contact lenses worn first and galyfilcon A prototype contact lenses worn second.
 Device: galyfilcon A prototype
silicone hydrogel contact lens
Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180985

Locations
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Virginia
Fincastle, Virginia, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01180985     History of Changes
Other Study ID Numbers: CR-1636BD
Study First Received: August 11, 2010
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013