Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens When Compared to Acuvue Advance Toric Soft Contact Lens
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| First Received Date ICMJE | October 5, 2012 | ||||||||||||
| Last Updated Date | October 12, 2012 | ||||||||||||
| Start Date ICMJE | May 2012 | ||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01706770 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens When Compared to Acuvue Advance Toric Soft Contact Lens | ||||||||||||
| Official Title ICMJE | Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens (Test) When Compared to Acuvue Advance Toric (Galyfilcon A) Soft Contact Lens (Control) | ||||||||||||
| Brief Summary | The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 4 | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Myopia | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Daily Disposable Contact Lens Wear
Interventions:
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Enrollment ICMJE | 52 | ||||||||||||
| Estimated Completion Date | October 2012 | ||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Prior to being considered eligible to participate in this study, each subject MUST:
Exclusion Criteria: Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present. To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye. |
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01706770 | ||||||||||||
| Other Study ID Numbers ICMJE | FC111216 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Coopervision, Inc. | ||||||||||||
| Study Sponsor ICMJE | Coopervision, Inc. | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Coopervision, Inc. | ||||||||||||
| Verification Date | October 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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