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: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Myopia
Device: senofilcon A
Device: lotrafilcon B
Device: balafilcon A
Device: metafilcon A
Device: vifilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • limbal hyperemia (redness) at 2 weeks [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest

  • limbal hyperemia (redness) at 4 weeks [ Time Frame: After 4 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest

  • bulbar hyperemia (redness) at 2 weeks [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest

  • bulbar hyperemia (redness) at 4 weeks [ Time Frame: After 4 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest

  • corneal staining at 2 weeks [ Time Frame: After 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest

  • corneal staining at 4 weeks [ Time Frame: After 4 weeks of lens wear ] [ Designated as safety issue: No ]
    Scale of 0 to 4, where 0 is lowest and 4 is greatest


Enrollment: 71
Study Start Date: May 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: senofilcon A
contact lens
Device: senofilcon A
contact lens
Active Comparator: lotrafilcon B
contact lens
Device: lotrafilcon B
contact lens
Active Comparator: balafilcon A
contact lens
Device: balafilcon A
contact lens
Active Comparator: metafilcon A
contact lens
Device: metafilcon A
contact lens
Active Comparator: vifilcon A
contact lens
Device: vifilcon A
contact lens

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912028

Locations
Brazil
Salvador, BA, Brazil, 41810-570
Recife, PE, Brazil, 51020-031
Maringá, PR, Brazil, 87014-110
Rio de Janeiro, RJ, Brazil, 22640-100
Campinas, SP, Brazil, 13092-320
Marilia, SP, Brazil, 17519-030
Ribeirão Preto, SP, Brazil, 14049-900
Santo André, SP, Brazil, 09060-650
São Paulo, SP, Brazil, 04063-000
São Paulo, SP, Brazil, 04534-000
São Paulo, SP, Brazil, 05409-001
Sponsors and Collaborators
Vistakon
Investigators
Principal Investigator: Carlos E Leite Arieta, MD, PhD Associate Professor - Ophthalmolgy, University of Campinas, Brazil
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00912028     History of Changes
Other Study ID Numbers: AOH--BRA-001
Study First Received: May 29, 2009
Last Updated: March 13, 2014
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014