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| Name | Class |
|---|---|
| Hartwig Research Center | INDUSTRY |
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Comparison of different contact lens materials.
This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive 65 | Experimental | The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
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| Definitive 74 | Active Comparator | The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive 65 | Other |
| ||
| Definitive 74 |
| 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 three months |
| 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 three months |
| 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 three months |
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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 |
|---|---|---|---|---|---|---|
| Siehste | Kassel | Germany | ||||
| Kresinsky |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| Würzburg |
| Germany |