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

Vertex Pharmaceuticals

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Ophthalmologic examinations; Drug: Ivacaftor Exposed

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01863238

VX12-770-115

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

95 participants in 1 patient group

Ivacaftor Treated

Treatment:

Drug: Ivacaftor Exposed

Other: Ophthalmologic examinations