Myopia
Conditions
Brief summary
This study compares the performance of an investigational contact lens to a currently marketed lens.
Interventions
DEVICEgalyifilcon A control lens
Marketed daily wear contact lens
DEVICEgalyfilcon A with a silver additive
Investigational daily wear contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject must be at least 18 years of age. 2. Both males and females may be enrolled. 3. The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form. 4. The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.
Exclusion criteria
1. The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear. 2. Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology. 3. Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia. 4. The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver. 5. Moderate or above corneal distortion by keratometry. 6. Known allergy to silver, silver ions, or silver containing compounds. 7. Abnormal discoloration of the cornea and/or conjunctiva. 8. Routine exposure to silver, silver ions, or silver containing compounds. 9. The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS) 10. Free of systemic and infectious diseases: hepatitis and tuberculosis. 11. Subjects must be HIV negative. 12. The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued). 13. The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye. 14. The subject must not have more than 1.00D of refractive astigmatism in either eye. 15. The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D. 16. The subject must not be monovision corrected. 17. The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution. 18. The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars) 19. The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment. 20. The subject must not have had an eye injury within 8 weeks prior to study enrollment. 21. The subject must not have had previous eye surgery. 22. The subject must be successfully trial fitted with the study contact lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings | 6 months | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported. |
| Subject Reported Symptoms | 6 months | Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported. |
| Visual Acuity | 6 months | Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts. |
| Average Contact Lens Wear Time | 6 Months | The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 529 subjects were enrolled in this study. Of those enrolled subjects, 33 did not meet the eligibility criteria and 496 were randomized to either the test or control lens using a 2:1 allocation. Of those randomized subjects 491 were successfully dispensed. Of the dispensed subjects 454 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Galyfilcon A w/ Silver Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study. | 326 |
| Galyfilcon A Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study. | 165 |
| Total | 491 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Diagnosed with Diabetes | 1 | 0 |
| Overall Study | Diagnosed with Multiple Scletosis | 1 | 0 |
| Overall Study | Gastric Surgery | 0 | 1 |
| Overall Study | Headaches | 1 | 0 |
| Overall Study | Lens Discomfort | 4 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Pregnancy | 6 | 3 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Subject became Ineligible | 1 | 1 |
| Overall Study | Subject relocated | 1 | 0 |
| Overall Study | Unsatisfactory Physiological Response | 0 | 1 |
| Overall Study | Unsatisfactory visual Response | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Galyfilcon A w/ Silver | Galyfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 31.9 years | 29.8 years | 30.9 years |
| Race/Ethnicity, Customized African American | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Asian | 5 participants | 4 participants | 9 participants |
| Race/Ethnicity, Customized Asian - Indian | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 8 participants | 9 participants | 17 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White | 304 participants | 147 participants | 451 participants |
| Region of Enrollment United States | 326 participants | 165 participants | 491 participants |
| Sex: Female, Male Female | 226 Participants | 98 Participants | 324 Participants |
| Sex: Female, Male Male | 100 Participants | 67 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 326 | 0 / 165 |
| serious Total, serious adverse events | 0 / 326 | 1 / 165 |
Outcome results
Primary
Average Contact Lens Wear Time
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Time frame: 6 Months
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Galyfilcon A w/ Silver | Average Contact Lens Wear Time | 14.0 time in hours |
| Galyfilcon A | Average Contact Lens Wear Time | 14.0 time in hours |
Primary
Slit Lamp Findings
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Time frame: 6 months
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Galyfilcon A w/ Silver | Slit Lamp Findings | 7 Number of Subject Eyes |
| Galyfilcon A | Slit Lamp Findings | 2 Number of Subject Eyes |
Primary
Subject Reported Symptoms
Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported.
Time frame: 6 months
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A w/ Silver | Subject Reported Symptoms | Other | 4.9 Percentage of Observations |
| Galyfilcon A w/ Silver | Subject Reported Symptoms | Irritation / Discomfort | 2.8 Percentage of Observations |
| Galyfilcon A w/ Silver | Subject Reported Symptoms | Cloudy/ Blurry / Hazy | 2.8 Percentage of Observations |
| Galyfilcon A w/ Silver | Subject Reported Symptoms | Dryness | 9.9 Percentage of Observations |
| Galyfilcon A | Subject Reported Symptoms | Cloudy/ Blurry / Hazy | 2.5 Percentage of Observations |
| Galyfilcon A | Subject Reported Symptoms | Other | 4.0 Percentage of Observations |
| Galyfilcon A | Subject Reported Symptoms | Dryness | 6.3 Percentage of Observations |
| Galyfilcon A | Subject Reported Symptoms | Irritation / Discomfort | 2.3 Percentage of Observations |
Primary
Visual Acuity
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
Time frame: 6 months
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A w/ Silver | Visual Acuity | 0.004 LogMAR | Standard Deviation 0.0891 |
| Galyfilcon A | Visual Acuity | -0.009 LogMAR | Standard Deviation 0.0866 |