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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT01863238
• Date of registration: 22/05/2013
• Prospective Registration: No
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
• Scientific title: An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
• Date of first enrolment: May 2013
• Target sample size: 95
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01863238
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Subject must reside in the US and be receiving or planning to receive
commercially-available ivacaftor.

Exclusion Criteria:

1. Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is
mandated by the protocol.

2. Subject has received surgery for cataracts



Age minimum: 6 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Other: Ophthalmologic examinations

Drug: Ivacaftor Exposed

Primary Outcome(s)

Cataracts (lens opacities) [Time Frame: Through Month 24]

Best corrected distance vision [Time Frame: Through Month 24]

Secondary ID(s)

VX12-770-115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics