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 27, 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: methafilcon 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) [ 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.


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: methafilcon A
contact lens
Device: methafilcon 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
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: 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, 05409-001
São Paulo, SP, Brazil, 04063-000
São Paulo, SP, Brazil, 04534-000
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
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on October 22, 2014