Hyperopia, Myopia
Conditions
Keywords
adverse events
Brief summary
This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.
Interventions
DEVICEnarafilcon B daily disposable soft contact lenses
daily disposable soft contact lenses
DEVICEetafilcon A daily disposable soft contact lenses
daily disposable soft contact lenses
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged \>8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses. * The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form. * The registrant must sign the Release of Medical Records in the event of an adverse event in the study. * The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
* Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses). * Current participant in an unrelated research study. * Employee or family member of Recruiting Practitioner or Johnson & Johnson.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Self-report at 2 Week, 4 Month or 12 Month surveys | Adverse events were reported by subjects via the electronic surveys if they responded yes to the question Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?. Consensus diagnosis was made after review of clinical records by Adjudication Panel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | Baseline, 2 Week, 4 Month or 12 Month surveys | The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-Day ACUVUE TruEye Contact Lens Users 1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses | 601 |
| 1-Day ACUVUE MOIST Contact Lens Users 1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses | 570 |
| Total | 1,171 |
Baseline characteristics
| Characteristic | 1-Day ACUVUE MOIST Contact Lens Users | 1-Day ACUVUE TruEye Contact Lens Users | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 121 Participants | 106 Participants | 227 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 445 Participants | 484 Participants | 929 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 12.9 | 33.2 years STANDARD_DEVIATION 13.9 | 31.8 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 570 participants | 601 participants | 1171 participants |
| Sex: Female, Male Female | 392 Participants | 400 Participants | 792 Participants |
| Sex: Female, Male Male | 178 Participants | 201 Participants | 379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 601 | 0 / 570 |
| serious Total, serious adverse events | 0 / 601 | 0 / 570 |
Outcome results
Primary
Incidence of Adverse Events
Adverse events were reported by subjects via the electronic surveys if they responded yes to the question Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?. Consensus diagnosis was made after review of clinical records by Adjudication Panel.
Time frame: Self-report at 2 Week, 4 Month or 12 Month surveys
Population: The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-Day ACUVUE TruEye Contact Lens Users | Incidence of Adverse Events | Yes to Red Eye Question, but no Office Visit | 6 participants |
| 1-Day ACUVUE TruEye Contact Lens Users | Incidence of Adverse Events | CL-Related Adverse Events with Office Visit | 8 participants |
| 1-Day ACUVUE TruEye Contact Lens Users | Incidence of Adverse Events | Not CL-Related Adverse Events with Office Visit | 5 participants |
| 1-Day ACUVUE TruEye Contact Lens Users | Incidence of Adverse Events | Corneal Infiltrative Events | 2 participants |
| 1-Day ACUVUE MOIST Contact Lens Users | Incidence of Adverse Events | Yes to Red Eye Question, but no Office Visit | 5 participants |
| 1-Day ACUVUE MOIST Contact Lens Users | Incidence of Adverse Events | Corneal Infiltrative Events | 0 participants |
| 1-Day ACUVUE MOIST Contact Lens Users | Incidence of Adverse Events | Not CL-Related Adverse Events with Office Visit | 2 participants |
| 1-Day ACUVUE MOIST Contact Lens Users | Incidence of Adverse Events | CL-Related Adverse Events with Office Visit | 3 participants |
Secondary
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).
Time frame: Baseline, 2 Week, 4 Month or 12 Month surveys
Population: The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-Day ACUVUE TruEye Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | Baseline, n=368, 320 | 12.8 units on a scale | Standard Deviation 7.2 |
| 1-Day ACUVUE TruEye Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 2 weeks, n=418,400 | 7.3 units on a scale | Standard Deviation 5.2 |
| 1-Day ACUVUE TruEye Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 4 months, n=418,400 | 8.7 units on a scale | Standard Deviation 5.7 |
| 1-Day ACUVUE TruEye Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 12 months, n=418,400 | 9.0 units on a scale | Standard Deviation 6.3 |
| 1-Day ACUVUE MOIST Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 12 months, n=418,400 | 9.2 units on a scale | Standard Deviation 6.1 |
| 1-Day ACUVUE MOIST Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | Baseline, n=368, 320 | 12.3 units on a scale | Standard Deviation 7.2 |
| 1-Day ACUVUE MOIST Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 4 months, n=418,400 | 9.3 units on a scale | Standard Deviation 6.2 |
| 1-Day ACUVUE MOIST Contact Lens Users | Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | 2 weeks, n=418,400 | 8.0 units on a scale | Standard Deviation 5.5 |