Myopia
Conditions
Brief summary
Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).
Interventions
DEVICEetafilcon A
DEVICEgalyfilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject must be at least 18 years of age. * The subject must read and sign the statement of informed consent and be provided with a copy of the form. * Minimum of 7 days of successful lens wear * Contact lens prescription requiring between -1.00 to -6.00 D spherical power * Less than 1.00 D of astigmatism in either eye
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks | Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit. |
| Rate of Contact Lens Related Serious and Significant Events (SSE) | Throughout the duration of the study (1 Year) | The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic. |
Countries
United States
Participant flow
Pre-assignment details
504 Subjects were enrolled in this study. 1 subject did not meet the eligibility. 2 subjects were randomized to the control lens group, but were not dispensed lenses. 247 subjects were randomized to the Control lens and 254 subjects were randomized to the Test lens.
Participants by arm
| Arm | Count |
|---|---|
| Control: Etafilcon A Subjects that were randomized to receive the Control lens etafilcon A | 247 |
| Test: Galyfilcon A Subjects that were randomized to receive the Test lens galyfilcon A | 254 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 6 |
| Overall Study | Coating on Lens | 1 | 0 |
| Overall Study | Diabetic | 1 | 0 |
| Overall Study | Discomfort | 11 | 16 |
| Overall Study | Dispensed incorrect test article | 1 | 2 |
| Overall Study | Excessive Dryness | 0 | 1 |
| Overall Study | History of Ocular Surgery | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 8 |
| Overall Study | Pregnancy | 1 | 5 |
| Overall Study | Protocol Violation | 4 | 10 |
| Overall Study | Relocation | 4 | 4 |
| Overall Study | Scheduling Conflict | 0 | 2 |
| Overall Study | Subject Ineligible/Dispensed | 9 | 6 |
| Overall Study | Unacceptable Fit | 0 | 1 |
| Overall Study | Unsatisfactory Physiological Response | 1 | 1 |
| Overall Study | Unsatisfactory Visual Response | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Control: Etafilcon A | Test: Galyfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 31.7 years | 32.8 years | 32.2 years |
| Race/Ethnicity, Customized African-American | 16 participants | 13 participants | 29 participants |
| Race/Ethnicity, Customized Asian | 11 participants | 10 participants | 21 participants |
| Race/Ethnicity, Customized Asian-Indian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 12 participants | 13 participants | 25 participants |
| Race/Ethnicity, Customized Other | 4 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized White | 203 participants | 217 participants | 420 participants |
| Region of Enrollment United States | 247 participants | 254 participants | 501 participants |
| Sex: Female, Male Female | 150 Participants | 172 Participants | 322 Participants |
| Sex: Female, Male Male | 97 Participants | 82 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 247 | 43 / 254 |
| serious Total, serious adverse events | 0 / 247 | 1 / 254 |
Outcome results
Primary
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
Time frame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
Population: The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 12-week Follow-up, N=388, 370 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 1-week Follow-up, N=393, 366 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 4-week Follow-up, N=392, 370 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 24-week Follow-up, N=390, 370 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 36-week Follow-up, N=390 , 365 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 52-week Follow-up, N=390, 368 | 0 Percentage of Subjects Eyes |
| Control: Etafilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 24-Hr. Follow-up, N=396, 370 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 36-week Follow-up, N=390 , 365 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 24-Hr. Follow-up, N=396, 370 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 24-week Follow-up, N=390, 370 | .27 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 1-week Follow-up, N=393, 366 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 52-week Follow-up, N=390, 368 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 4-week Follow-up, N=392, 370 | 0 Percentage of Subjects Eyes |
| Test: Galyfilcon A | Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 | 12-week Follow-up, N=388, 370 | 0 Percentage of Subjects Eyes |
Primary
Rate of Contact Lens Related Serious and Significant Events (SSE)
The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.
Time frame: Throughout the duration of the study (1 Year)
Population: All subjects that were dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control: Etafilcon A | Rate of Contact Lens Related Serious and Significant Events (SSE) | 2.4 percentage of Subjects |
| Test: Galyfilcon A | Rate of Contact Lens Related Serious and Significant Events (SSE) | 5.9 percentage of Subjects |