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Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Galyfilcon A Habitual Lens
Galyfilcon A 8.7 BC (Investigational)
Galyfilcon A 8.3 BC (Investigational)
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., at least 18 years old)
  • Sign a written informed consent
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D
  • Have spectacle astigmatism <1.25D in each eye
  • Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

  • Required concurrent ocular medication
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial
  • Known allergy to silver, silver ions, or silver containing compounds.

Sites / Locations

  • Coles-Brennan Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3

Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL

GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7

Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3

Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7

Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL

Arm Description

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Outcomes

Primary Outcome Measures

Comparison of Lens Fit Characteristics
At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): Visual Acuity (logMar) Over-refraction with Visual Acuity Fit acceptability (acceptable/non-acceptable)
Evaluation of Inter-Changeability
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale)
Determination of fit or Vision Differences
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale)

Secondary Outcome Measures

Full Information

First Posted
January 21, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Coles-Brennan Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01054807
Brief Title
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2009 (Actual)
Primary Completion Date
March 1, 2010 (Actual)
Study Completion Date
March 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Coles-Brennan Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Arm Type
Other
Arm Description
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Arm Title
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Arm Type
Other
Arm Description
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Arm Title
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Arm Type
Other
Arm Description
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Arm Title
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Arm Type
Other
Arm Description
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Arm Title
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Arm Type
Other
Arm Description
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Arm Title
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Arm Type
Other
Arm Description
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention Type
Device
Intervention Name(s)
Galyfilcon A Habitual Lens
Intervention Description
Comparison of three soft contact lens designs.
Intervention Type
Device
Intervention Name(s)
Galyfilcon A 8.7 BC (Investigational)
Intervention Description
Comparison of three soft contact lens designs.
Intervention Type
Device
Intervention Name(s)
Galyfilcon A 8.3 BC (Investigational)
Intervention Description
Comparison of three soft contact lens designs
Primary Outcome Measure Information:
Title
Comparison of Lens Fit Characteristics
Description
At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): Visual Acuity (logMar) Over-refraction with Visual Acuity Fit acceptability (acceptable/non-acceptable)
Time Frame
Approximately 40 minutes of wear time
Title
Evaluation of Inter-Changeability
Description
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale)
Time Frame
Approximately 40 minutes of wear time
Title
Determination of fit or Vision Differences
Description
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale)
Time Frame
Approximately 40 minutes of wear time

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., at least 18 years old) Sign a written informed consent Have contact lens distance sphere requirement in the range -1.00D to -6.00D Have spectacle astigmatism <1.25D in each eye Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription. Have normal eyes with no evidence of abnormality or disease. Exclusion Criteria: Required concurrent ocular medication Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Abnormal lacrimal secretions Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial Known allergy to silver, silver ions, or silver containing compounds.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Brennan, McOptom PhD
Organizational Affiliation
Coles-Brennan Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coles-Brennan Pty Ltd
City
Hawthorn
State/Province
Victoria
ZIP/Postal Code
3122
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

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