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| Name | Class |
|---|---|
| Jens Medical Consulting Ltd. | UNKNOWN |
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The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxysoft | Experimental | olifilcon C, daily disposable soft contact lens, 1 month |
|
| SiHy | Active Comparator | olifilcon B, dialy disposable soft contact lens, 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxysoft (olifilcon C) | Device | subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log MAR visual acuities | The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| slit lamp findings | Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huey Chuan Cheng, MD MSc | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation | New Taipei City | 231 | Taiwan | |||
| Tri-Service General Hospital_Tingjhou |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Si-Hy (olifilcon B) | Device | subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality. |
|
| Taipei |
| 100 |
| Taiwan |
| MayKay Memorial Hospital | Taipei | 10449 | Taiwan |