Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01484028
First received: November 30, 2011
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.


Condition Intervention
Myopia
Device: etafilcon A control lenses
Device: etafilcon A lenses for light eyes
Device: etafilcon A for dark eyes lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Monocular Visual Acuity [ Time Frame: after one week of lens wear ] [ Designated as safety issue: No ]
    logMAR scoring/calculations, standard scale

  • Lens Fit Acceptance [ Time Frame: after one week of lens wear ] [ Designated as safety issue: No ]
    Lens fit per eye will evaluated by the investigator and determined to be acceptable or unacceptable

  • Corneal Staining of Grade 3 or above [ Time Frame: after one week of lens wear ] [ Designated as safety issue: Yes ]
    A scale of grades from 0 to 4, where 0=None, 1=Trace, 2=Mild, 3= Moderate, 4=Severe. Percent of eyes with a grade of 3 or 4 will be reported.


Enrollment: 275
Study Start Date: November 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
etafilcon A for light eyes / etafilcon A control
Subjects will wear etafilcon A for light eyes lenses during the first period and etafilcon A control lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A lenses for light eyes
new etafilcon A lenses designed for light eyes, for daily wear, daily lens replacement
etafilcon A control / etafilcon A for light eyes
Subjects will wear etafilcon A control lenses during the first period and etafilcon A for light eyes lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A lenses for light eyes
new etafilcon A lenses designed for light eyes, for daily wear, daily lens replacement
etafilcon A for dark eyes / etafilcon A control
Subjects will wear etafilcon A for dark eyes lenses during the first period and etafilcon A control lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A for dark eyes lenses
new etafilcon A lenses designed for dark eyes, for daily wear, daily lens replacement
etafilcon A control / etafilcon A for dark eyes
Subjects will wear etafilcon A control lens during the first period and etafilcon A for dark eyes lenses during the second period. Each period consists of daily lens wear, daily lens replacement for one week.
Device: etafilcon A control lenses
marketed etafilcon A lenses for daily wear, daily lens replacement
Device: etafilcon A for dark eyes lenses
new etafilcon A lenses designed for dark eyes, for daily wear, daily lens replacement

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy, female, adult, at least 18 years of age, and no more than 34 years of age
  • Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
  • Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
  • Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
  • Any cylinder power must be: <=0.75D
  • Visual acuity must be best correctable to 20/25 or better for each eye
  • Must have normal eyes (no ocular medications or ocular infection of any type)
  • Must read and sign the Statement of Informed Consent
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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
  • Any color deficiencies (colorblindness) - to the best of the subject's knowledge
  • 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.
  • Subject presents with one dark iris color and one light iris color.
  • Subject has heterochromia iridis (a difference in color between parts of one iris).
  • The subject must not be an employee or family member of the clinical study site.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484028

Locations
United States, California
Site 1
Mission Viejo, California, United States, 92691
Site 2
Mission Viejo, California, United States, 92691
United States, Florida
Jacksonville, Florida, United States, 32256
United States, Illinois
Bloomington, Illinois, United States, 61701
United States, Kansas
Pittsburg, Kansas, United States, 66762
United States, New York
Vestal, New York, United States, 13850
United States, Oregon
Grants Pass, Oregon, United States, 97526
United States, Texas
Katy, Texas, United States, 77450
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
United States, Wyoming
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01484028     History of Changes
Other Study ID Numbers: CR-005094
Study First Received: November 30, 2011
Last Updated: June 4, 2012
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