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Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable contact lens (hexafocon b) test when worn on a daily wear basis in the correction of myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.
Subjects who meet all eligible requirements for entry into the study will be instructed to insert the Hi-Brite Large Diameter Rigid Gas Permeable contact lens in daily wear basis for clinical evaluation purposes.
Treatment period: 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scleral lenses | Experimental | Subjects who meet all eligible requirements for entry into the study will be instructed to insert the Hi-Brite Large Diameter Rigid Gas Permeable contact lens in daily wear basis for clinical evaluation purposes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens | Device | Approximately At least one hundred and forty (140) subjects (280 eyes) will be enrolled in this study at approximately two (2) clinical sites in Taiwan. All subjects will be fitted for and dispensed study lenses by each Investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of the vision with correction |
| Wearing the contact lens for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of each visit |
|
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Inclusion criteria:
Exclusion criteria:
The subject is ineligible for entry into the study if the subject
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| Name | Affiliation | Role |
|---|---|---|
| Tsung-Jen Wang, Dr. | Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| wearing the contact lens for 6 months |
| The rate of Treatment-Emergent Adverse Events to assess the safety of each visit | To assess the rate of adverse reactions, the proportion of corneal ulcers, the proportion of continuous stroma edema, significant proportion of corneal staining of luciferase, the proportion of corneal infections, the proportion of persistent inflammation of the eyelids, and the proportion of other eye discomfort. | wearing the contact lens for 6 months |