An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
Official title: An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
Clinical Trials gov number: NCT01863238
Click on the tabs to move through the sequence.
Purpose: To evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of paediatric CF patients who are aged ≤11 years at initiation of ivacaftor treatment and are receiving or planning to receive commercially-available ivacaftor in the US.
Phase: NA
Type: Observational, prospective, cohort
Study sponsor: Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation Therapeutics
- Reside in the US and be receiving or planning to receive commercially-available ivacaftor
Intervention
Ivacaftor
Geographical Location
United States
Number of Participants
51-100 (6-11 years)
Primary Endpoint
At Month 24
- Cataracts (lens opacities)
- Best corrected distance vision
Secondary Endpoint
Not provided
Click on the tabs to move through the sequence.