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Clinical Performance Comparison of Several Different Contact Lenses

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ClinicalTrials.gov Identifier: NCT00912028
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : April 28, 2014
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Myopia Device: senofilcon A Device: lotrafilcon B Device: balafilcon A Device: methafilcon A Device: vifilcon A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
Actual Study Start Date : May 1, 2009
Actual Primary Completion Date : February 1, 2010
Actual Study Completion Date : February 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Limbal Hyperemia (Redness) [ Time Frame: 2 weeks ]
    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.

  2. Limbal Hyperemia (Redness) [ Time Frame: 4 weeks ]
    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.

  3. Bulbar Hyperemia (Redness) [ Time Frame: 2 weeks ]
    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.

  4. Bulbar Hyperemia (Redness) [ Time Frame: 4 weeks ]
    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.

  5. Corneal Staining [ Time Frame: 2 weeks ]
    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.

  6. Corneal Staining [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Johnson & Johnson Vision Care, Inc.
Investigators
Principal Investigator: Carlos E Leite Arieta, MD, PhD Associate Professor - Ophthalmolgy, University of Campinas, Brazil

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00912028     History of Changes
Other Study ID Numbers: AOH--BRA-001
First Posted: June 3, 2009    Key Record Dates
Results First Posted: April 28, 2014
Last Update Posted: September 19, 2017
Last Verified: August 2017