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COMPLETED

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

NCT01863238 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • OTHER Ophthalmologic examinations
  • DRUG Ivacaftor Exposed

Study Locations (20)

Michigan

  • — Ann Arbor
  • — Detroit

Missouri

  • — Columbia
  • — Kansas City

Alabama

  • — Birmingham

Arizona

  • — Tucson

California

  • — Long Beach

Colorado

  • — Aurora

Delaware

  • — Wilmington

Florida

  • — St. Petersburg

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2013-05
Est. Completion 2016-05

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01863238

The ClinicalTrials.gov registry entry for NCT01863238 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions — of which Ophthalmologic examinations is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01863238 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Michigan, Missouri, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01863238 about?

NCT01863238 is a clinical study titled "An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis". 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 ar...

What is the current status of trial NCT01863238?

This trial is currently completed. The enrollment target is 95 participants. The study started on 2013-05. Estimated completion is 2016-05.

What conditions does trial NCT01863238 study?

This clinical trial studies the following conditions: Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01863238?

The interventions under investigation include: Ophthalmologic examinations (OTHER), Ivacaftor Exposed (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01863238?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01863238 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial