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Drug & research development » Clinical trials » NCT01863238

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

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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

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Not provided

View Trial Results