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Sponsored by: |
Coopervision, Inc. |
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Information provided by: | Coopervision, Inc. |
ClinicalTrials.gov Identifier: | NCT00597467 |
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
Condition | Intervention | Phase |
---|---|---|
Ametropia |
Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens Device: Acuvue 2 Soft Contact Lens |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen |
Enrollment: | 455 |
Study Start Date: | March 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
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2: Active Comparator |
Device: Acuvue 2 Soft Contact Lens
Control device
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
Subjects must read, indicate understanding of, and sign the Informed Consent Form.
Study Director: | William Gleason, OD | FRS |
Responsible Party: | Coopervision, Inc. ( Lisa Hahn ) |
Study ID Numbers: | CVI060105 |
Study First Received: | December 27, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00597467 History of Changes |
Health Authority: | United States: Food and Drug Administration |
myopia hyperopia extended wear ametropia |
Hyperopia Eye Diseases Myopia Refractive Errors |
Eye Diseases Refractive Errors |