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Clinical Performance Comparison of Two Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
senofilcon A
lotrafilcon B
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Existing daily soft lens wearer.
  • Require a distance visual correction in both eyes.
  • Have a contact lens spherical distance refraction between -1.00D and -6.00D.
  • Have refractive astigmatism less than or equal to 1.00D in both eyes.
  • Achieve 20/30 or better corrected distance acuity.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

  • Requires presbyopic correction.
  • Requires ocular medications.
  • Grade 3 or 4 ocular abnormalities.
  • Grade 3 corneal staining in more than one region.
  • Has had refractive surgery.
  • Any other injury or ocular surgery within 8 weeks prior to study enrollment.
  • Has abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Has keratoconus or other corneal irregularity.
  • Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
  • Wears habitual contact lenses that are toric, multifocal or worn extended wear.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
  • Diabetic.
  • Infectious or immunosuppressive disease.
  • History of chronic eye disease (e.g glaucoma or age related macular degeneration).
  • Pregnancy, lactation or planning pregnancy at time of enrollment.
  • Participation in any concurrent clinical trial or in another trial in the last 30 days.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

senofilcon A both eyes

lotrafilcon B both eyes

Arm Description

soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.

soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

Outcomes

Primary Outcome Measures

Average Corneal Staining
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Visual Acuity
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Overall Comfort
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Overall Comfort
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary Outcome Measures

Limbal Redness
The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Bulbar Redness
The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Symptoms of Dryness
Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None

Full Information

First Posted
September 10, 2009
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00975585
Brief Title
Clinical Performance Comparison of Two Contact Lenses
Official Title
Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2009 (Actual)
Primary Completion Date
October 1, 2009 (Actual)
Study Completion Date
October 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the clinical performance of two 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
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
senofilcon A both eyes
Arm Type
Active Comparator
Arm Description
soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
Arm Title
lotrafilcon B both eyes
Arm Type
Active Comparator
Arm Description
soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
soft contact lens, 2-week replacement indicated
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Intervention Description
soft contact lens with a 4-week replacement indicated.
Primary Outcome Measure Information:
Title
Average Corneal Staining
Description
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
2 weeks
Title
Visual Acuity
Description
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
2 weeks
Title
Overall Comfort
Description
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
2 weeks
Title
Overall Comfort
Description
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Limbal Redness
Description
The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
2 weeks
Title
Bulbar Redness
Description
The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Time Frame
2 weeks
Title
Symptoms of Dryness
Description
Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Existing daily soft lens wearer. Require a distance visual correction in both eyes. Have a contact lens spherical distance refraction between -1.00D and -6.00D. Have refractive astigmatism less than or equal to 1.00D in both eyes. Achieve 20/30 or better corrected distance acuity. Have normal eyes with no evidence of abnormality or disease. Exclusion Criteria: Requires presbyopic correction. Requires ocular medications. Grade 3 or 4 ocular abnormalities. Grade 3 corneal staining in more than one region. Has had refractive surgery. Any other injury or ocular surgery within 8 weeks prior to study enrollment. Has abnormal lacrimal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Has keratoconus or other corneal irregularity. Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks. Wears habitual contact lenses that are toric, multifocal or worn extended wear. Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear. Diabetic. Infectious or immunosuppressive disease. History of chronic eye disease (e.g glaucoma or age related macular degeneration). Pregnancy, lactation or planning pregnancy at time of enrollment. Participation in any concurrent clinical trial or in another trial in the last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila, B Hickson-Curran, BSc, MCOptom
Organizational Affiliation
Johnson & Johnson Vision Care, Inc.
Official's Role
Study Director
Facility Information:
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72116
Country
United States
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02140
Country
United States
City
Blue Springs
State/Province
Missouri
ZIP/Postal Code
64015
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
City
Chagrin Falls
State/Province
Ohio
ZIP/Postal Code
44023
Country
United States
City
North Olmsted
State/Province
Ohio
ZIP/Postal Code
44070
Country
United States
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
City
Chamberlain
State/Province
South Dakota
ZIP/Postal Code
57325
Country
United States
City
Hot Springs
State/Province
South Dakota
ZIP/Postal Code
57747
Country
United States
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
757703
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

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Clinical Performance Comparison of Two Contact Lenses

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