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The objective of this study is to demonstrate that the OxyAqua 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 from one hospital. 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 |
|---|---|---|---|
| OxyAqua | Experimental | OxyAqua (olifilcon D) daily disposable |
|
| Si-Hy | Active Comparator | Si-Hy (olifilcon B) daily disposable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyAqua | Device | OxyAqua (olifilcon D) silicone hydrogel soft contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Log MAR visual acuity (VA) | the visual acuity corrected with contact lens could reach 0.1 or better | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Any slit lamp findings > grade 2 | 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. | over all follow-up visits for the 1 month |
| Subjective response to comfort, symptoms and complaints |
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Inclusion Criteria:
Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics:
VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
1.00 to -10.00 D myopia, astigmatism less than 2.00 D
Willing to comply with all study procedures and be available for the duration of the study.
Provide signed and dated informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huey Chuan Cheng, MD MDS | Mackay Memorial Hospital | Study Director |
| Shu-I Yeh, MD MS | MacKay Memorial Hospital - Tamshui | Principal Investigator |
| Jy Been Liang, MD | Tri-Service General Hopsital - Tingjhou Branch | Principal Investigator |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Si-Hy |
| Device |
Si-Hy (oliflcon B) silicone hydrogel soft contact lens |
|
subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 5=No stinging/Burning for each eye |
| over all follow-up visits for the 1 month |