A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
An Open-label, Pilot Study to Assess the Safety, Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
1 other identifier
interventional
3
1 country
1
Brief Summary
The objective of this study is to collect preliminary efficacy and safety data on the use of EDTA EYE Drops (EED) on subjects during an episode of band keratopathy (BK).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJanuary 5, 2022
January 1, 2022
1.3 years
June 7, 2019
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes of the Cornea
Photographs will be full, direct views taken with a Zeiss model 450 plus split lamp camera.
Days 1, 120 and 180 after the start of the study.
Change in Snellen Visual Acuity
The Snellen Chart is used to assess visual acuity by asking subjects to read as many of the 11 lines of block letters as they are able.
Days 1, 7, 60, 120 and 180 after the start of the study.
Change in the Symptoms Associated with Band Keratopathy
Evaluation of pain, as rated by the subject on a visual analog scale, will be the primary symptom assessed throughout this study.
Days 1, 7, 60, 180, 270, 360, 540 and 720 after the start of the study.
Study Arms (1)
Drops Used
EXPERIMENTALInterventions
One drop in the Band Keratopathy affected eye only, two times per day for six months.
Eligibility Criteria
You may qualify if:
- Understand the requirements of the study and provide informed consent prior to undergoing any study-related procedures
- Be between the ages of 40 and 80 years old, inclusive
- Have a documented BK diagnosis
- Be willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of symptoms
You may not qualify if:
- Use other therapies for BK including amniotic membrane or conjunctival grafts.
- Have other co-morbidities that may confound the safety and efficacy measurements for this study.
- Have participated in any other clinical trial within 30 days prior to enrollment.
- Have any condition, abnormality or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Livionex Inc.collaborator
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 13, 2019
Study Start
June 29, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
January 5, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share