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

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Ophthalmologic examinations; Drug: Ivacaftor Exposed

• Registration Number: NCT01863238
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Status Verified: 2015-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ivacaftor Treated	Ivacaftor Exposed	-
Ivacaftor Treated	Ophthalmologic examinations	-

Primary Outcome Measures

Name	Time	Method
Cataracts (lens opacities)	Through Month 24
Best corrected distance vision	Through Month 24