Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Hawthorn, Victoria, Australia, 3122

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. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Sequence 1; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 2; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 3; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 4; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 5; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 6; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 7; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 8; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 9; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer
OTHER: Sequence 10; 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	Device: galyfilcon A; contact lenses worn bilaterally for 8-12 hours; Device: galyfilcon A plus; contact lenses worn bilaterally for 8-12 hours; Device: lotrafilcon A; contact lenses worn bilaterally for 8-12 hours; Device: polymacon; contact lenses worn bilaterally for 8-12 hours; Other: spectacles; habitual spectacles owned by subject, non-specific manufacturer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	after 8 hours of lens wear
Limbal Redness	grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.	after 8 hours of lens wear
Endothelia Blebs	0 to 100% of area; measured as a percentage of corneal area with blebs.	after 20 minutes of lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (ESTIMATE): December 1, 2011

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-005031