An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

Completed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01863238

Run by

Vertex Pharmaceuticals Incorporated

People needed

95

Starts

2013-05-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-23

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Long Beach, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Portland, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Rochester, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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