Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00241280|
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : February 25, 2016
Last Update Posted : March 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: etafilcon A Device: galyfilcon A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
Active Comparator: Control
etafilcon A contact lens being worn 7 days/6 nights.
|Device: etafilcon A|
galyfilcon A contact lens being worn 7 days/6 nights.
|Device: galyfilcon A|
- Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 [ Time Frame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks ]Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
- Rate of Contact Lens Related Serious and Significant Events (SSE) [ Time Frame: Throughout the duration of the study (1 Year) ]The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241280
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