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This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group myopia control | Experimental | Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control |
|
| Myopia Control | Active Comparator | Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens | Device | Daily Wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Snelling Scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Grading by the Slit Lamp Classification Scale | 3 months |
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Inclusion Criteria:
Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:
Use no ocular medication.
Have no known sensitivity to solutions currently used for contact lens care.
Have binocular correction with contact lenses.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| John M Szabocsik, PhD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenda Secor, OD | Huntington Beach | California | 92647 | United States | ||
| Randall Sakamoto |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens | Device |
|
| Honolulu |
| Hawaii |
| 96814 |
| United States |
| Robert Davis, OD | Oak Lawn | Illinois | 60453 | United States |
| Douglas P. Benoit, OD, FAAO | Concord | New Hampshire | 03301 | United States |
| Stephen P. Byrnes, OD, FAAO | Londonderry | New Hampshire | 03053 | United States |