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Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
galyfilcon A
galyfilcon A plus
lotrafilcon A
polymacon
spectacles
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be of legal age (i.e. 18 years)
  • Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
  • Be mentally competent, willing and able to sign a written informed consent form.
  • Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
  • Have spectacle astigmatism <1.25D in each eye
  • Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
  • Have had an oculo-visual examination within the previous 12 months.

  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No evidence of lid abnormality or infection
    • No conjunctival abnormality or infection
    • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
    • No other active ocular disease

Exclusion Criteria:

  • Requires concurrent ocular medication.
  • Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Has had refractive surgery.
  • Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
  • History of abnormal lachrymal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Extended lens wear in last 3 months.
  • PMMA, hybrid or RGP lens wear in the previous 8 weeks
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Has diabetes
  • Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of chronic eye disease (e.g. glaucoma or ARMD).
  • Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial or in last 30 days.
  • Family member or employee of the clinical site, investigator or other study staff.
  • Currently wears habitual contact lenses on an EW basis.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Other

Other

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Sequence 7

Sequence 8

Sequence 9

Sequence 10

Arm Description

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Lotrafilcon A Spectacles Galyfilcon A Plus Polymacon Galyfilcon A

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Plus Galyfilcon A Lotrafilcon A Polymacon Spectacles

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Polymacon Galyfilcon A Plus Spectacles Lotrafilcon A

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Spectacles Lotrafilcon A Polymacon Galyfilcon A Plus Galyfilcon A

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Polymacon Galyfilcon A Spectacles Galyfilcon A Plus Lotrafilcon A

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Galyfilcon A Plus Polymacon Lotrafilcon A Spectacles

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Polymacon Spectacles Galyfilcon A Lotrafilcon A Galyfilcon A Plus

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Plus Lotrafilcon A Galyfilcon A Spectacles Polymacon

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Lotrafilcon A Galyfilcon A Plus Spectacles Galyfilcon A Polymacon

Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Spectacles Polymacon Lotrafilcon A Galyfilcon A Galyfilcon A Plus

Outcomes

Primary Outcome Measures

Corneal Swelling
measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
Limbal Redness
grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Endothelia Blebs
0 to 100% of area; measured as a percentage of corneal area with blebs.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2011
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01482819
Brief Title
Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
December 1, 2011 (Actual)
Study Completion Date
December 1, 2011 (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 this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

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
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Lotrafilcon A Spectacles Galyfilcon A Plus Polymacon Galyfilcon A
Arm Title
Sequence 2
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Plus Galyfilcon A Lotrafilcon A Polymacon Spectacles
Arm Title
Sequence 3
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Polymacon Galyfilcon A Plus Spectacles Lotrafilcon A
Arm Title
Sequence 4
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Spectacles Lotrafilcon A Polymacon Galyfilcon A Plus Galyfilcon A
Arm Title
Sequence 5
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Polymacon Galyfilcon A Spectacles Galyfilcon A Plus Lotrafilcon A
Arm Title
Sequence 6
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Galyfilcon A Plus Polymacon Lotrafilcon A Spectacles
Arm Title
Sequence 7
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Polymacon Spectacles Galyfilcon A Lotrafilcon A Galyfilcon A Plus
Arm Title
Sequence 8
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Galyfilcon A Plus Lotrafilcon A Galyfilcon A Spectacles Polymacon
Arm Title
Sequence 9
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Lotrafilcon A Galyfilcon A Plus Spectacles Galyfilcon A Polymacon
Arm Title
Sequence 10
Arm Type
Other
Arm Description
Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: Spectacles Polymacon Lotrafilcon A Galyfilcon A Galyfilcon A Plus
Intervention Type
Device
Intervention Name(s)
galyfilcon A
Intervention Description
contact lenses worn bilaterally for 8-12 hours
Intervention Type
Device
Intervention Name(s)
galyfilcon A plus
Intervention Description
contact lenses worn bilaterally for 8-12 hours
Intervention Type
Device
Intervention Name(s)
lotrafilcon A
Intervention Description
contact lenses worn bilaterally for 8-12 hours
Intervention Type
Device
Intervention Name(s)
polymacon
Intervention Description
contact lenses worn bilaterally for 8-12 hours
Intervention Type
Other
Intervention Name(s)
spectacles
Intervention Description
habitual spectacles owned by subject, non-specific manufacturer
Primary Outcome Measure Information:
Title
Corneal Swelling
Description
measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
Time Frame
after 8 hours of lens wear
Title
Limbal Redness
Description
grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Time Frame
after 8 hours of lens wear
Title
Endothelia Blebs
Description
0 to 100% of area; measured as a percentage of corneal area with blebs.
Time Frame
after 20 minutes of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be of legal age (i.e. 18 years) Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A) Be mentally competent, willing and able to sign a written informed consent form. Have contact lens distance sphere requirement in the range 1.00D to 6.00D. Have spectacle astigmatism <1.25D in each eye Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications Have had an oculo-visual examination within the previous 12 months. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection No conjunctival abnormality or infection No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities) No other active ocular disease Exclusion Criteria: Requires concurrent ocular medication. Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. Has had refractive surgery. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study. History of abnormal lachrymal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Extended lens wear in last 3 months. PMMA, hybrid or RGP lens wear in the previous 8 weeks Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Has diabetes Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). History of chronic eye disease (e.g. glaucoma or ARMD). Pregnancy, lactating, or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial or in last 30 days. Family member or employee of the clinical site, investigator or other study staff. Currently wears habitual contact lenses on an EW basis.
Facility Information:
City
Hawthorn
State/Province
Victoria
ZIP/Postal Code
3122
Country
Australia

12. IPD Sharing Statement

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Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

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