An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 11 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | June 2016 |
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.
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.
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
We found this trial at
39
sites
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