Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Keratolysis, sponsored by Joseph B. Ciolino, MD.
NCT02863809 is a Phase 1 study of Keratolysis that has completed, run by Joseph B. Ciolino, MD. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.
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
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 1 |
What the finished NCT02863809 record still lists
NCT02863809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
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 lists 13 locations in 11 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02863809's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02615184 · 76 participants · Phase 2
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
- NCT02821741 · 76 participants · NA
Effects of External Ear Stimulation on Pain Perception and Mood
- NCT03019757 · 76 participants
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- NCT03353584 · 76 participants · NA
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI