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The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens.
The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.
Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSiHy (test lens) | Experimental |
| |
| Silicone hydrogel soft contact lens CE-marked for daily use | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSiHy Silicone hydrogel soft contact lens | Device | ā¢Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations. | 13 week visit | |
| Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit. | 13 week visit | |
| Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit. | 13 week visit |
| Measure | Description | Time Frame |
|---|---|---|
| The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4) | Assessed by sector with fluorescein, blue light, yellow filter and full beam using medium magnification. 0 NONE: No staining
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Atsushi Uchida | Contact | +81 3 5913 2378 | atsushi.uchida@hoya.com |
| Name | Affiliation | Role |
|---|---|---|
| Graeme Young, Dr | Visioncare Research Ltd. | Principal Investigator |
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| CE-marked Silicone hydrogel soft contact lens | Device | ć»Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Other Name : MyDay |
|
| 13 week visit |
| The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4) | Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present
| 13 week visit |
| The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4). | Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present
| 13 week visit |
| The following variables will be compared between lens types: Comfort (0-10) | Assessed by subject. 0 to 10 scale 10 = cannot be felt 0 = painful | 13 week visit |
| The following variables will be compared between lens types: Visual acuity (logMAR VA) | 13 week visit |
| The following variables will be compared between lens types: Wettability (0-4). | Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0 VERY POOR: Immediately displaying non-wetting areas on lens surface.
| 13 week visit |