An observational study in Myopia and Hyperopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 37 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Johnson & Johnson Vision Care, Inc. · Observational
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.
140 studies on the registry are indexed under Hyperopia; 18 are open to participants now.
This study's enrollment of 1,171 is above the median of 174 across 24 observational studies indexed under Hyperopia.
Browse Hyperopia studies →Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.
Exclusion Criteria:
1-Day ACUVUE TruEye contact lens users
Device: narafilcon B daily disposable soft contact lenses
1-Day ACUVUE MOIST contact lens users
Device: etafilcon A daily disposable soft contact lenses
daily disposable soft contact lenses
Also known as: 1-Day ACUVUE TruEye
daily disposable soft contact lenses
Also known as: 1-Day ACUVUE MOIST
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
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
| Milestone | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users |
|---|---|---|
| Started | 601 | 570 |
| 2 week survey completed | 551 | 522 |
| 4 month survey completed | 533 | 493 |
| 12 month survey completed | 502 | 463 |
| Completed | 502 | 463 |
| Not completed | 99 | 107 |
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.
| participants | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users |
|---|---|---|
| Corneal Infiltrative Events | 2 | 0 |
| CL-Related Adverse Events with Office Visit | 8 | 3 |
| Not CL-Related Adverse Events with Office Visit | 5 | 2 |
| "Yes" to Red Eye Question, but no Office Visit | 6 | 5 |
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).
| units on a scale | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users |
|---|---|---|
| Baseline, n=368, 320 | 12.8 ± 7.2 | 12.3 ± 7.2 |
| 2 weeks, n=418,400 | 7.3 ± 5.2 | 8.0 ± 5.5 |
| 4 months, n=418,400 | 8.7 ± 5.7 | 9.3 ± 6.2 |
| 12 months, n=418,400 | 9.0 ± 6.3 | 9.2 ± 6.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1-Day ACUVUE TruEye Contact Lens Users | — | 0/601 (0%) | 0/601 (0%) |
| 1-Day ACUVUE MOIST Contact Lens Users | — | 0/570 (0%) | 0/570 (0%) |
| Age, Categorical(Participants) | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users | Total |
|---|---|---|---|
| <=18 years | 106 | 121 | 227 |
| Between 18 and 65 years | 484 | 445 | 929 |
| >=65 years | 11 | 4 | 15 |
| Age, Continuous(years) | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users | Total |
|---|---|---|---|
| Mean | 33.2 ± 13.9 | 30.3 ± 12.9 | 31.8 ± 13.5 |
| Sex: Female, Male(Participants) | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users | Total |
|---|---|---|---|
| Female | 400 | 392 | 792 |
| Male | 201 | 178 | 379 |
| Region of Enrollment(participants) | 1-Day ACUVUE TruEye Contact Lens Users | 1-Day ACUVUE MOIST Contact Lens Users | Total |
|---|---|---|---|
| United States | 601 | 570 | 1171 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.