NCT01863238 is a clinical trial of Ophthalmologic examinations in Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Who is sponsoring NCT01863238?

NCT01863238 is sponsored by Vertex Pharmaceuticals Incorporated.

What drugs are being tested in NCT01863238?

Interventions in NCT01863238: Ophthalmologic examinations, Ivacaftor Exposed.

What condition does NCT01863238 study?

NCT01863238 studies Cystic Fibrosis.

Is NCT01863238 still recruiting?

NCT01863238 is currently completed. Last updated 22 August 2016.

Last reviewed 2016-08-22 · How we verify

NCT01863238

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 22 August 2016

What this trial tests

trial testing Ophthalmologic examinations in Cystic Fibrosis in 95 participants. Completed in 1 May 2016.

Timeline

1 May 2013

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Vertex Pharmaceuticals Incorporated
Status	Completed
Study type	OBSERVATIONAL
Enrollment	95
Start date	1 May 2013
Primary completion	1 May 2016
Estimated completion	1 May 2016
Sites	38 locations across United States

Drugs / interventions tested

Ophthalmologic examinations
Ivacaftor Exposed — full drug profile →

Conditions studied

Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Vertex Pharmaceuticals Incorporated — full company profile →

Who can join

Adults 6 to 11, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cataracts (lens opacities)
Time frame: Through Month 24
Best corrected distance vision
Time frame: Through Month 24

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.
Skilton M, Krishan A, Patel S, Sinha IP, et al · · 2019 · cited 18× · PMID 30616300 · DOI 10.1002/14651858.cd009841.pub3
Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency.
Rose K, Spigarelli MG. · · 2015 · cited 2× · PMID 27417354 · DOI 10.3390/children2010108

Verify or expand the search:

Other trials of Ophthalmologic examinations

Trials testing the same drug.

NCT03288844 — Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns · completed

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting

Other Vertex Pharmaceuticals Incorporated trials

Trials by the same sponsor.

NCT05951205 — Evaluation of Efficacy and Safety of a Single Dose of Exa-cel in Participants With Severe Sickle Cell Disease, βS/ βC Ge · Phase 3 · withdrawn
NCT07501702 — A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis · Phase 2 · not yet recruiting
NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07378865 — Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants · Phase 1 · recruiting
NCT07349394 — Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01863238 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated
Last refreshed: 22 August 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01863238.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing