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NCT02863809 · ClinicalTrials.gov registry record · Phase 1

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

A Phase 1 study of Keratolysis, sponsored by Joseph B. Ciolino, MD.

Completed
Registry status
Phase 1
Development phase
76
Enrollment target
13
Study locations

NCT02863809 is a Phase 1 study of Keratolysis that has completed, run by Joseph B. Ciolino, MD. The registered enrollment target is 76 participants. The trial reports 13 study locations across 11 states.

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The verdict

NCT02863809, a Phase 1 study of Keratolysis, has completed, sponsored by Joseph B. Ciolino, MD.

COMPLETED
Registry status
Phase 1
Development phase
76 participants
Enrollment target
13
Study locations

Study Summary

This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

Conditions Studied

Interventions

  • DRUG Riboflavin
  • DRUG Dextran
  • DEVICE UVA Light Source

Study Locations (13)

California

  • The Jules Stein Eye Institute - Los Angeles
  • UC Davis Health System Eye Center - Sacramento
  • Shiley Eye Institute, University of California, San Diego - San Diego

Florida

  • Bascom Palmer eye Institute - Miami

Illinois

  • Illinois Eye and Ear Infirmary - Chicago

Kentucky

  • Cincinnati Eye Institute - Edgewood

Maryland

  • Wilmer Eye Institute - Baltimore

Michigan

  • W.K. Kellogg Eye Center - Ann Arbor

Missouri

  • Tauber Eye Center - Kansas City

New York

  • David and Ilene Flaum Eye Institute, University of Rochester - New York

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2017-03-15
Est. Completion 2021-08-31
Phase Phase 1

Sponsor

Joseph B. Ciolino, MD

4 total trials

What the Registry Record Tells You About NCT02863809

The ClinicalTrials.gov registry entry for NCT02863809 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph B. Ciolino, MD, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Keratolysis appearing as the primary indexed condition, and to 3 interventions - of which Riboflavin is the first listed.

NCT02863809 reports 13 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT02863809 about?

NCT02863809 is a clinical study titled "Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit". This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because...

What is the current status of trial NCT02863809?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2017-03-15. Estimated completion is 2021-08-31.

What conditions does trial NCT02863809 study?

This clinical trial studies the following conditions: Keratolysis.

What interventions are being tested in trial NCT02863809?

The interventions under investigation include: Riboflavin (DRUG), Dextran (DRUG), UVA Light Source (DEVICE).

Who is sponsoring clinical trial NCT02863809?

This trial is sponsored by Joseph B. Ciolino, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02863809 being conducted?

This trial has 13 study locations across California, Florida, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.