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| Name | Class |
|---|---|
| Hartwig Research Center | INDUSTRY |
Comparison of different contact lens materials.
This is a 1-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 HPT | Experimental | The Test product were the Definitive 65 (Filcon V4) lenses with Hydra PEG surface coating. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
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| Definitive 65 | Active Comparator | The Control product was the commercially available Definitive 65 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive 65 HPT contact lenses | Device |
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| |
| 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 | Assessed using slit lamp with white light, low-medium magnification. 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 |
| conjunctival redness - ocular biomicroscopy | Assessed using slit lamp with white light, low-medium magnification. 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 | Assessed using slit lamp with white light, low-medium magnification. 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, FAAO | Hartwig Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siehste | Kassel | Germany | ||||
| Kresinky |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Definitive 65 contact lenses |
| Device |
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| Würzburg |
| Germany |