Back to resultsClinical Performance Comparison of Several Different Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
senofilcon A
lotrafilcon B
balafilcon A
methafilcon A
vifilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
senofilcon A
lotrafilcon B
balafilcon A
methafilcon A
vifilcon A
Arm Description
contact lens
contact lens
contact lens
contact lens
contact lens
Outcomes
Primary Outcome Measures
Limbal Hyperemia (Redness)
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)
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)
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)
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00912028
First Posted
May 29, 2009
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00912028
Brief Title
Clinical Performance Comparison of Several Different Contact Lenses
Official Title
Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
February 1, 2010 (Actual)
Study Completion Date
February 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
senofilcon A
Arm Type
Active Comparator
Arm Description
contact lens
Arm Title
lotrafilcon B
Arm Type
Active Comparator
Arm Description
contact lens
Arm Title
balafilcon A
Arm Type
Active Comparator
Arm Description
contact lens
Arm Title
methafilcon A
Arm Type
Active Comparator
Arm Description
contact lens
Arm Title
vifilcon A
Arm Type
Active Comparator
Arm Description
contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
vifilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Limbal Hyperemia (Redness)
Description
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.
Time Frame
2 weeks
Title
Limbal Hyperemia (Redness)
Description
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.
Time Frame
4 weeks
Title
Bulbar Hyperemia (Redness)
Description
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.
Time Frame
2 weeks
Title
Bulbar Hyperemia (Redness)
Description
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.
Time Frame
4 weeks
Title
Corneal Staining
Description
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.
Time Frame
2 weeks
Title
Corneal Staining
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Leite Arieta, MD, PhD
Organizational Affiliation
Associate Professor - Ophthalmolgy, University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
City
Salvador
State/Province
BA
ZIP/Postal Code
41810-570
Country
Brazil
City
Recife
State/Province
PE
ZIP/Postal Code
51020-031
Country
Brazil
City
Maringá
State/Province
PR
ZIP/Postal Code
87014-110
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22640-100
Country
Brazil
City
Campinas
State/Province
SP
ZIP/Postal Code
13092-320
Country
Brazil
City
Marilia
State/Province
SP
ZIP/Postal Code
17519-030
Country
Brazil
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
04063-000
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
04534-000
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
05409-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Clinical Performance Comparison of Several Different Contact Lenses
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