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The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiSight 1 Day | Experimental | MiSight 1 Day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiSight 1 Day | Device | Subjects will wear MiSight 1 day lenses for three years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Microbial Keratitis (MK) | Incidence of Microbial Keratitis (MK) ≥ 1 mm | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of peripheral infiltrative keratitis/non-infectious ulcers | Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm | 3 years |
| Incidence of non-infectious infiltrative keratitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Richdale | CooperVision International Limited (CVIL) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experts on Sight LLC. | Gilbert | Arizona | 85297 | United States | ||
| Centerton Family Eyecare |
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Incidence of non-infectious infiltrative keratitis ≤ 1 mm
| 3 years |
| Incidence of loss of best-corrected visual acuity | Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event. | 3 years |
| Centerton |
| Arkansas |
| 72719 |
| United States |
| University of California, Berkeley University Eye Center | Berkeley | California | 94720 | United States |
| Golden Vision Cupertino Optometry | Cupertino | California | 95014 | United States |
| Boghossian Vision | Danville | California | 94506 | United States |
| Iron Horse Optometric Group | Dublin | California | 94568 | United States |
| Capitol Eye Care Center Optometry | Fremont | California | 94536 | United States |
| Irvine Eye Physicians and Surgeons Inc | Irvine | California | 92618 | United States |
| Elsa Pao OD, Inc | Oakland | California | 94607 | United States |
| Perfect Pair Optometry | San Jose | California | 95118 | United States |
| Almaden Family Optometric Center | San Jose | California | 95120 | United States |
| Children's Eye Physicians | Centennial | Colorado | 80112 | United States |
| Eye Physicians & Surgeons, PC | Milford | Connecticut | 06460 | United States |
| Planet Vision Eyecare | Lake Worth | Florida | 33467 | United States |
| Marino Eye Care | Miami | Florida | 33156 | United States |
| Vision Source Oviedo, INC | Oviedo | Florida | 32765 | United States |
| Gulf Coast Eye Center | Sarasota | Florida | 34239 | United States |
| Dau Family Eye Care | St. Johns | Florida | 32259 | United States |
| Weston Contact Lens Institute LLC | Weston | Florida | 33331 | United States |
| Lurie Childrens | Chicago | Illinois | 60611 | United States |
| Lyons Family Eye Care P.C. | Chicago | Illinois | 60657 | United States |
| Darien Eye Specialists | Darien | Illinois | 60561 | United States |
| Carillon Vision Care | Glenview | Illinois | 60025 | United States |
| Little Eyes Pediatric Eye Care | Carmel | Indiana | 46032 | United States |
| All Eyes on Rockville | Rockville | Maryland | 20852 | United States |
| Wellesley Vision Group at Optical Design | Wellesley | Massachusetts | 02482 | United States |
| Missouri Eye Consultants - California | California | Missouri | 65018 | United States |
| Center for Vision and Learning | Des Peres | Missouri | 63131 | United States |
| Advocare Pediatric Eye Physicians | Morristown | New Jersey | 07960 | United States |
| Bronx Eye Associates | The Bronx | New York | 10467 | United States |
| Clarity Vision | Apex | North Carolina | 27502 | United States |
| Cary Family Eye Care | Cary | North Carolina | 27519 | United States |
| Chagrin Valley Optometrists, Inc. | Chagrin Falls | Ohio | 44023 | United States |
| Pickerington Eye Care | Pickerington | Ohio | 43147 | United States |
| Nittany Eye Associates, LLC | State College | Pennsylvania | 16801 | United States |
| Texas State Optical | Beaumont | Texas | 77706 | United States |
| Bellaire Family Eye Care | Bellaire | Texas | 77401 | United States |
| Drs. McIntyre, Garza, Avila and Jurica, Optometrists | Corpus Christi | Texas | 78411 | United States |
| Clarkson EyeCare KIDS | Frisco | Texas | 75034 | United States |
| Lone Star Vision Center | Plano | Texas | 75024 | United States |
| Stone Oak Vision Source | San Antonio | Texas | 78258 | United States |
| Child & Family Eye Care Center | Pleasant Grove | Utah | 84062 | United States |
| Broadway Eye Clinic | Salt Lake City | Utah | 84111 | United States |
| Invision Eye Health | Sandy City | Utah | 84070 | United States |
| Colonial Eye Care | Williamsburg | Virginia | 23185 | United States |
| Redmond Eye Clinic | Redmond | Washington | 98052 | United States |
| Spectrum Optical, PLLC | Morgantown | West Virginia | 26505 | United States |
| Dr. Kit Guan & Associates | Markham | Ontario | L3R3P9 | Canada |
| Abbey Eye Care | Oakville | Ontario | L6M5A9 | Canada |
| Optometry Professional Corporation | Toronto | Ontario | M2N 3A1 | Canada |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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