Refractive Error
Conditions
Brief summary
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
Interventions
DEVICEgalyfilcon A
galyfilcon A
DEVICEcomfilcon A
comfilcon A
Sponsors
Foresight Regulatory Strategies, Inc.
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes. * The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder. * The subject, based on his/her knowledge, must be in good general health. * The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations. * Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear. * Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. * Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period. * The subject must read, indicate understanding of and sign the Informed Consent Form.
Exclusion criteria
* The subject is a rigid gas permeable (RGP) or daily disposable lens wearer. * The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures. * The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.) * Slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium or corneal scars within the visual axis * neovascularization equal to or greater than 1mm in from the limbus * history of giant papillary conjunctivitis (GPC) worse than grade 2 * anterior uveitis or iritis (past or present) * seborrhoeic eczema * seborrhoeic conjunctivitis * A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. * A known history of corneal hypoesthesia (reduced corneal sensitivity). * Contact lens snellen visual acuities (VA) worse than 20/30. * Aphakia, keratoconus or a highly irregular cornea. * Current pregnancy or lactation (to the best of the subject's knowledge) * Any active participation in another clinical study at any time during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort | 1-week, 2- weeks | \>0 = comfortable, \<0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. |
| Comfort Symptoms | 1-week, 2-weeks | A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. \>0 = comfortable, \<0 = uncomfortable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Corneal Staining | 2 weeks | Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Completed Population Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study. | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Ineligible | 1 | 0 |
| First Intervention | Lens Issue | 1 | 1 |
| First Intervention | Lost to Follow-up | 0 | 2 |
| First Intervention | Protocol Violation | 0 | 1 |
| Second Intervention | Protocol Violation | 3 | 3 |
Baseline characteristics
| Characteristic | Completed Population |
|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 46 |
| serious Total, serious adverse events | 0 / 51 | 0 / 46 |
Outcome results
Primary
Comfort Symptoms
A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. \>0 = comfortable, \<0 = uncomfortable
Time frame: 1-week, 2-weeks
Population: Only participants who completed the study per protocol (n=78)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A | Comfort Symptoms | 0.2440 score | Standard Error 0.1262 |
| Comfilcon A | Comfort Symptoms | -0.02862 score | Standard Error 0.1275 |
Comparison: Results is overall lens effect with time as a covariate.98.3% CI: [0.04553, 0.2726]Mixed Models Analysis
Primary
Lens Comfort
\>0 = comfortable, \<0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
Time frame: 1-week, 2- weeks
Population: Only participants who completed the study per protocol (n=78)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A | Lens Comfort | 0.1452 combined score | Standard Error 0.1097 |
| Comfilcon A | Lens Comfort | 0.1135 combined score | Standard Error 0.1112 |
Comparison: Results is overall lens effect with time as a covariate.98.3% CI: [-0.2346, 0.03164]Mixed Models Analysis
Secondary
Overall Corneal Staining
Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Time frame: 2 weeks
Population: Only the participants who completed the study per protocol (n=78)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A | Overall Corneal Staining | 0.07582 combined score | Standard Error 0.02192 |
| Comfilcon A | Overall Corneal Staining | 0.07026 combined score | Standard Error 0.02192 |
Comparison: Results is overall lens effect with time as a covariate.98.3% CI: [-0.04297, 0.00556]Mixed Models Analysis