Myopia
Conditions
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.
Interventions
DEVICEgalyfilcon A
contact lenses worn bilaterally for 8-12 hours
DEVICEgalyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
DEVICElotrafilcon A
contact lenses worn bilaterally for 8-12 hours
DEVICEpolymacon
contact lenses worn bilaterally for 8-12 hours
OTHERspectacles
habitual spectacles owned by subject, non-specific manufacturer
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelia Blebs | after 20 minutes of lens wear | 0 to 100% of area; measured as a percentage of corneal area with blebs. |
| 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 23.7 years STANDARD_DEVIATION 6.11 |
| Race/Ethnicity, Customized Asian | 5 participants |
| Race/Ethnicity, Customized Multiple | 16 participants |
| Region of Enrollment Australia | 21 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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)
Time frame: after 8 hours of lens wear
Population: Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spectacles | Corneal Swelling | 569.42 microns | Standard Deviation 36.0709 |
| Galyfilcon A Plus | Corneal Swelling | 574.64 microns | Standard Deviation 39.7804 |
| Galyfilcon A | Corneal Swelling | 575.57 microns | Standard Deviation 37.6229 |
| Lotrafilcon A | Corneal Swelling | 578.99 microns | Standard Deviation 41.496 |
| Polymacon | Corneal Swelling | 573.79 microns | Standard Deviation 36.1644 |
Primary
Endothelia Blebs
0 to 100% of area; measured as a percentage of corneal area with blebs.
Time frame: after 20 minutes of lens wear
Population: Subjects who were enrolled, randomized and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spectacles | Endothelia Blebs | 4.97 percentage of area | Standard Deviation 3.3703 |
| Galyfilcon A Plus | Endothelia Blebs | 8.86 percentage of area | Standard Deviation 3.9396 |
| Galyfilcon A | Endothelia Blebs | 10.93 percentage of area | Standard Deviation 6.602 |
| Lotrafilcon A | Endothelia Blebs | 10.31 percentage of area | Standard Deviation 6.6747 |
| Polymacon | Endothelia Blebs | 8.50 percentage of area | Standard Deviation 3.6 |
Primary
Limbal Redness
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
Population: Subjects who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spectacles | Limbal Redness | 0.66 units on a scale | Standard Deviation 0.2479 |
| Galyfilcon A Plus | Limbal Redness | 0.83 units on a scale | Standard Deviation 0.3023 |
| Galyfilcon A | Limbal Redness | 0.77 units on a scale | Standard Deviation 0.3085 |
| Lotrafilcon A | Limbal Redness | 0.91 units on a scale | Standard Deviation 0.3087 |
| Polymacon | Limbal Redness | 1.14 units on a scale | Standard Deviation 0.3363 |