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It was decided by the sponsor to not proceed.
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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 | daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating |
|
| untreated | Experimental | daily wear Hexafocon A rigid contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPT treatment | Device |
|
| |
| 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 |
| limbal redness - ocular biomicroscopy | Findings were 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 | Findings were 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:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Hartwig, PhD | Hartwig Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartwig Research Center | Heikendorf | S-H | 24226 | Germany | ||
| Siehste |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| untreated |
| Device |
|
| Kassel |
| Germany |