Clinical Performance Comparison of Several Different Contact Lenses

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 41810-570
    • PE
      • Recife, PE, Brazil, 51020-031
    • PR
      • Maringá, PR, Brazil, 87014-110
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22640-100
    • SP
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
4 weeks
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.
2 weeks
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.
4 weeks
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.
2 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Vision Care, Inc.

Investigators

  • Principal Investigator: Carlos E Leite Arieta, MD, PhD, Associate Professor - Ophthalmolgy, University of Campinas, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOH--BRA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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