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Comparison of Three Soft Bifocal Contact Lenses

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
balafilcon A
senofilcon A production
senofilcon A test
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 respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
  • The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
  • Refractive cylinder must be less than or equal to -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 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 a contagious immunosuppressive disease (e.g., HIV).
  • History of diabetes. History of binocular vision abnormality or strabismus.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

senofilA test/senofilA prod/balafilconA

senofilcon A test/balafilcon A/senofilcon A prod

senofilcon A prod/senofilcon A test/balafilcon A

senofilcon A prod/ balifilcon A/ senofilcon A test

balafilcon A/senofilcon A test/senofilcon A prod

balafilcon A/senofilcon A prod/senofilcon A test

Arm Description

Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.

Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.

Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.

Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.

Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.

Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.

Outcomes

Primary Outcome Measures

Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Type of Corneal Staining
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).
Overall Subjective Vision
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00808340
Brief Title
Comparison of Three Soft Bifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2008 (Actual)
Primary Completion Date
December 1, 2008 (Actual)
Study Completion Date
December 1, 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 primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the 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
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
senofilA test/senofilA prod/balafilconA
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
Arm Title
senofilcon A test/balafilcon A/senofilcon A prod
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
Arm Title
senofilcon A prod/senofilcon A test/balafilcon A
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
Arm Title
senofilcon A prod/ balifilcon A/ senofilcon A test
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
Arm Title
balafilcon A/senofilcon A test/senofilcon A prod
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
Arm Title
balafilcon A/senofilcon A prod/senofilcon A test
Arm Type
Active Comparator
Arm Description
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.
Intervention Type
Device
Intervention Name(s)
balafilcon A
Intervention Description
multifocal contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A production
Intervention Description
multifocal contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A test
Intervention Description
multifocal contact lens
Primary Outcome Measure Information:
Title
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Description
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
5 minutes after insertion
Title
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Description
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
5 minutes after insertion
Title
Type of Corneal Staining
Description
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).
Time Frame
after 1 week of lens wear, for each lens type
Title
Overall Subjective Vision
Description
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Time Frame
after 1 week of lens wear, for each lens type

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 respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.). The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. Refractive cylinder must be less than or equal to -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 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 a contagious immunosuppressive disease (e.g., HIV). History of diabetes. History of binocular vision abnormality or strabismus.
Facility Information:
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Three Soft Bifocal Contact Lenses

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