Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: galyfilcon A
Device: galyfilcon A plus
Device: lotrafilcon A
Device: polymacon
Other: spectacles

Registration Number: NCT01482819

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sequence 1	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: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 1	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: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 3	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: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 1	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: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 1	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: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 1	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: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 2	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: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 3	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: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 2	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: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 4	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: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 5	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: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 3	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: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 3	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: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 4	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: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 4	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: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 5	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: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 4	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: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 5	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: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 5	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: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 2	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: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 2	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: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 2	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: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 3	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: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 6	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: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 6	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: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 7	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: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 7	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: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 6	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: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 4	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: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 6	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: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 6	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: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 10	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: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus
Sequence 10	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: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus
Sequence 9	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: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 5	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: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 8	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: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 9	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: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 10	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: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus
Sequence 7	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: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 7	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: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 8	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: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 9	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: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 7	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: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 8	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: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 8	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: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 8	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: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 9	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: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 9	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: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 10	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: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus
Sequence 10	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: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus

Primary Outcome Measures

Name	Time	Method
Corneal Swelling	after 8 hours of lens wear	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	after 8 hours of lens wear	grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Endothelia Blebs	after 20 minutes of lens wear	0 to 100% of area; measured as a percentage of corneal area with blebs.