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| Name | Class |
|---|---|
| Hartwig Research Center | INDUSTRY |
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This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPT treated | Experimental | Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D |
|
| untreated | Active Comparator | untreated RGP contact lenses made from roflufocon D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roflufocon D contact lenses | Device | HPT treated rigid contact lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| questionnaire addressing subjective comfort and wear time | Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'. | subjects will be followed-up for one month |
| conjunctival redness - ocular biomicroscopy | Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe. | subjects will be followed-up for one month |
| corneal staining - ocular biomicroscopy | Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe. | subjects will be followed-up for one month |
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Inclusion Criteria:
Exclusion Criteria:• Eye injury or surgery within 3 months immediately prior to enrolment for this trial
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Hartwig, PhD, FAAO | Hartwig Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siehste | Kassel | Germany |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| RGP contact lenses made from roflufocon D |
| Device |
|