An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
NCT ID: NCT01863238
Last Updated: 2016-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
95 participants
OBSERVATIONAL
2013-05-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ivacaftor Treated
Ophthalmologic examinations
Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.
Ivacaftor Exposed
Interventions
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Ophthalmologic examinations
Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.
Ivacaftor Exposed
Eligibility Criteria
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Inclusion Criteria
2. Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.
Exclusion Criteria
2. Subject has received surgery for cataracts
6 Years
11 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Long Beach, California, United States
Aurora, Colorado, United States
Wilmington, Delaware, United States
St. Petersburg, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Rochester, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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VX12-770-115
Identifier Type: -
Identifier Source: org_study_id
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