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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Hawthorn, Victoria, Australia, 3122
      • Coles-Brennan Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3; Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs
Other: Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL; Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs
Other: GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7; Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs
Other: Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3; Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs
Other: Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7; Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs
Other: Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL; Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)	Device: Galyfilcon A Habitual Lens; Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.7 BC (Investigational); Comparison of three soft contact lens designs.; Device: Galyfilcon A 8.3 BC (Investigational); Comparison of three soft contact lens designs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Approximately 40 minutes of wear time
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)	Approximately 40 minutes of wear time
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)	Approximately 40 minutes of wear time

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Coles-Brennan Pty Ltd
• Investigators: Principal Investigator: Noel Brennan, McOptom PhD, Coles-Brennan Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0915; CTN# 155/2009 (Registry Identifier: Therapeutics Goods Aministration (TGA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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