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Clinical Performance Comparison of Several Different Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00912028
First received: May 29, 2009
Last updated: October 28, 2014
Last verified: October 2014

May 29, 2009
October 28, 2014
May 2009
February 2010   (final data collection date for primary outcome measure)
  • Limbal Hyperemia (Redness) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • Limbal Hyperemia (Redness) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • Bulbar Hyperemia (Redness) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • Bulbar Hyperemia (Redness) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • Corneal Staining [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • Corneal Staining [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
  • limbal and bulbar hyperemia [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • lens wear time [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • corneal staining [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • subjective comfort ratings [ Time Frame: after 2 weeks of lens wear ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00912028 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Performance Comparison of Several Different Contact Lenses
Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • Device: senofilcon A
    contact lens
  • Device: lotrafilcon B
    contact lens
  • Device: balafilcon A
    contact lens
  • Device: methafilcon A
    contact lens
  • Device: vifilcon A
    contact lens
  • Active Comparator: senofilcon A
    contact lens
    Intervention: Device: senofilcon A
  • Active Comparator: lotrafilcon B
    contact lens
    Intervention: Device: lotrafilcon B
  • Active Comparator: balafilcon A
    contact lens
    Intervention: Device: balafilcon A
  • Active Comparator: methafilcon A
    contact lens
    Intervention: Device: methafilcon A
  • Active Comparator: vifilcon A
    contact lens
    Intervention: Device: vifilcon A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
Not Provided
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must:

  • be existing soft contact lens wearers of the study control lenses
  • require a distance visual correction in both eyes
  • have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
  • have astigmatism less than or equal to 1.00D in both eyes
  • be able to wear lenses available for this study
  • be corrected to a visual acuity of 6/9 (20/30) or better in each eye
  • have normal eyes with no evidence of abnormality or disease

Exclusion Criteria:

Subject are excluded for the following reasons:

  • monovision corrected
  • worn lenses extended wear in the last 3 months.
  • require concurrent ocular medication
  • grade 3 or 4 abnormalities
  • grade 3 corneal staining in more than two regions
  • anterior ocular surgery
  • any other ocular surgery or injury within 8 weeks prior to study enrollment
  • abnormal lachrymal secretions
  • pre-existing ocular irritation that would preclude contact lens fitting
  • corneal irregularities
  • Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
  • any systemic illness which would preclude contact lens wear
  • diabetes
  • infectious or immunosuppressive disease
  • pregnancy or lactating, or planning pregnancy at time or enrollment
  • participating in a concurrent clinical study or within last 60 days
  • allergy to the standardized study care solution
Both
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00912028
AOH--BRA-001
No
Vistakon
Vistakon
Not Provided
Principal Investigator: Carlos E Leite Arieta, MD, PhD Associate Professor - Ophthalmolgy, University of Campinas, Brazil
Vistakon
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP