Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-site, prospective, single-arm, open-label, real-world evidence study with a minimal study duration of 1-year, up to 2-year follow-up to evaluate overall visual acuity.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST Lens | Experimental | Eligible subjects will bilaterally wear the TEST Lens for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D) | Device | TEST Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length (AL) from baseline | AL will be measured, in mm, every 6 months throughout the study using an ocular biometer. | Up to 24-month follow-up |
| Change in Spherical Equivalent of Cycloplegic Autorefraction (SECAR) from baseline | SECAR will be measured, in diopter (D), every 6 months throughout the study using an autorefractor. | up to 24-month follow-up |
| Serious and significant ocular adverse events (AEs) | Number (n, %) of subjects and eyes with contact lens related (i.e., related and possibly related) serious and significant ocular adverse events (AEs) by diagnosis. | up to 24-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Distance LogMAR Visual Acuity | Monocular and binocular distance visual acuity will be measured at distance 4 meters under high luminance (120-200 cd/m2), high contrast (>600 lux) conditions using Landolt C logMAR visual acuity. | up to 24-month follow-up |
Not provided
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Boao Lecheng AIER Eye Hospital Co. LTD | Qionghai | Hainan | 571400 | China |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided