Corneal Dystrophy, Band-Shaped Clinical Trial
Official title:
An Open-label, Pilot Study to Assess the Safety, Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
Verified date | January 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 3 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Understand the requirements of the study and provide informed consent prior to undergoing any study-related procedures 2. Be between the ages of 40 and 80 years old, inclusive 3. Have a documented BK diagnosis 4. Be willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of symptoms Exclusion Criteria: 1. Use other therapies for BK including amniotic membrane or conjunctival grafts. 2. Have other co-morbidities that may confound the safety and efficacy measurements for this study. 3. Have participated in any other clinical trial within 30 days prior to enrollment. 4. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Livionex Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. |