Status:
COMPLETED
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-11 years
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 Cys...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
- Subject has received surgery for cataracts
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01863238
Start Date
May 1 2013
End Date
May 1 2016
Last Update
August 23 2016
Active Locations (38)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Long Beach, California, United States
4
Aurora, Colorado, United States