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Comparison of Two Soft Bifocal Contact Lenses

Primary Purpose

Presbyopia

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

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject must between 35 and 70 years of age.
  • The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
  • The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
  • Refractive cylinder must be -0.75 D in each eye.
  • The subject must have an ADD power of +0.75D to +2.50D in each eye.
  • The subject must have best corrected visual acuity of 20/20-3 or better in each eye
  • The subject's must have at least 20/30-distance vision OU with the study contact lenses.
  • The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria:

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear
  • Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of diabetes
  • History of binocular vision abnormality or strabismus

Sites / Locations

  • Dr. James Weber & Associates
  • Ted Brink & Associates
  • Eye Associates of Winter Park
  • Lee Rigel
  • Timothy R. Poling, OD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

senofilcon A / balafilcon A

balafilcon A/senofilcon A

Arm Description

senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second

balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second

Outcomes

Primary Outcome Measures

Distance Visual Acuity
This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal
Near Visual Acuity
This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.
Subject Vision
Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2008
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00724945
Brief Title
Comparison of Two Soft Bifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
senofilcon A / balafilcon A
Arm Type
Active Comparator
Arm Description
senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second
Arm Title
balafilcon A/senofilcon A
Arm Type
Active Comparator
Arm Description
balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
multifocal contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
multifocal contact lens
Primary Outcome Measure Information:
Title
Distance Visual Acuity
Description
This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal
Time Frame
after 1 week of wear
Title
Near Visual Acuity
Description
This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.
Time Frame
after 1 week wear
Title
Subject Vision
Description
Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Time Frame
after 1 week wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must between 35 and 70 years of age. The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction. The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye. Refractive cylinder must be -0.75 D in each eye. The subject must have an ADD power of +0.75D to +2.50D in each eye. The subject must have best corrected visual acuity of 20/20-3 or better in each eye The subject's must have at least 20/30-distance vision OU with the study contact lenses. The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses The subject must be an adapted soft contact lens wearer in both eyes. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. Exclusion Criteria: Ocular or systemic allergies or disease that may interfere with contact lens wear. Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). History of diabetes History of binocular vision abnormality or strabismus
Facility Information:
Facility Name
Dr. James Weber & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Ted Brink & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Eye Associates of Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Lee Rigel
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Timothy R. Poling, OD
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

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Comparison of Two Soft Bifocal Contact Lenses

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