An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
1 other identifier
observational
95
1 country
38
Brief Summary
This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2013
Typical duration for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 23, 2016
July 1, 2015
3 years
May 22, 2013
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cataracts (lens opacities)
Through Month 24
Best corrected distance vision
Through Month 24
Study Arms (1)
Ivacaftor Treated
Interventions
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.
Eligibility Criteria
Pediatric patients with CF who are 11 years of age or younger at the time of initiation of treatment with ivacaftor and are receiving or planning to receive commercially-available ivacaftor in the United States (US)
You may qualify if:
- Subject must be 11 years of age or younger at the time of treatment initiation with ivacaftor (as part of clinical trial) or commercially-available ivacaftor.
- Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.
You may not qualify if:
- Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
- Subject has received surgery for cataracts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vertex Pharmaceuticals Incorporatedlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (38)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Wilmington, Delaware, United States
Unknown Facility
St. Petersburg, Florida, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Portland, Maine, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Rochester, New York, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
Unknown Facility
Morgantown, West Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 27, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 23, 2016
Record last verified: 2015-07