Corneal Dystrophy, Band-ShapedEarly Phase 1NCT03985371
A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
A Early Phase 1 study testing EDTA Eye Drops in people with Corneal Dystrophy, Band-Shaped, run by University of Rochester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Corneal Dystrophy, Band-Shaped
- What is being tested?
- EDTA Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 30 Sep 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Pilot Study to Assess the Safety, Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
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).
Read the detailed description
This study is an open-label, pilot study of up to 6 subjects with documented BK.
This study has 2 phases: In Phase 1 subjects must be willing to return to the clinic for evaluation of safety and BK symptoms during the treatment period of 6 months (Days 7, 60, 120, 180) and for follow up at Months 9 and 12. In Phase 2 subjects must be willing to return to the clinic at 18 and 24 months post-first dose for a final evaluation.
On Day 1 of the study, potential subjects will be screened and if they meet entry requirements they will be enrolled in the study.
Once enrolled, subjects will be assessed for baseline symptoms and visual acuity, have corneal photographs taken of their affected eye, dispensed EED and instructed to use it for 2 times/day for 6 months in the eye with BK. They will be dosed for the first time in the clinic in order to show them how to consistently use the drops. Subjects will also be given a diary card to record potential adverse events and pain levels (with the first level being noted in the clinic), dismissed from the clinic and reminded to return on Day 7 for assessment of tolerability and safety.
At each subsequent visit (Days 7, 60, 120, 180) the subject will be asked to rate their pain at the time of the visit on a pain analog scale. Their diary card will be reviewed for potential adverse events (AEs) and use of EED will be assessed for technique and compliance. Between visits, subjects will be called every 4 weeks by a member of the study site team to assess potential AEs and dosing compliance.
Additionally, the subject or their caregiver will check the treated eye on a weekly basis and note whether the calcific bands are still present on the diary card. When bands have disappeared, subject will notify the eye clinic and schedule a return visit to obtain corneal photographs and visual acuity test. This may occur outside the planned study visits.
On Day 180, subjects will present at the clinic to return their diary card and unused study product. They will be asked to return to the clinic on Days 270 and 360 for assessment of their visual acuity, pain, corneal photography of the affected eye and potential AEs.
Day 360 will be considered the end of study phase 1. Phase 2 of the study includes long term follow up for possible recurrence. Subjects will be scheduled to return for follow-up visits at months 18 and 24 for assessment of visual acuity and recurrence of BK symptoms.
- Conditions
- Corneal Dystrophy, Band-Shaped
- Being tested
- EDTA Eye Drops
- Keywords
- Band Keratopathy
- Medical subject headings
- Corneal Dystrophy, Band-Shaped
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTA Eye DropsDrug
One drop in the Band Keratopathy affected eye only, two times per day for six months.
| Study group | Role | What they receive |
|---|---|---|
| Drops Used | Experimental | Not described Receives: Drug: EDTA Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the Cornea
Photographs will be full, direct views taken with a Zeiss model 450 plus split lamp camera.
Measured: 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.
Measured: 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.
Measured: Days 1, 7, 60, 180, 270, 360, 540 and 720 after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start29 Jun 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Dystrophy, Band-ShapedStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Livionex Inc.
- Responsible party
- Principal investigator, James V. Aquavella, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985371
- Sponsor's protocol ID
- 3712
- Status last verified
- Jan 2022
- First submitted
- 7 Jun 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Study to Assess the Safety, Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
- ClinicalTrials.gov ID
- NCT03985371
- Acronym / sponsor ID
- 3712
- Conditions
- Corneal Dystrophy, Band-Shaped
- Keywords
- Band Keratopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Livionex Inc.
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is an open-label, pilot study of up to 6 subjects with documented BK.
This study has 2 phases: In Phase 1 subjects must be willing to return to the clinic for evaluation of safety and BK symptoms during the treatment period of 6 months (Days 7, 60, 120, 180) and for follow up at Months 9 and 12. In Phase 2 subjects must be willing to return to the clinic at 18 and 24 months post-first dose for a final evaluation.
On Day 1 of the study, potential subjects will be screened and if they meet entry requirements they will be enrolled in the study.
Once enrolled, subjects will be assessed for baseline symptoms and visual acuity, have corneal photographs taken of their affected eye, dispensed EED and instructed to use it for 2 times/day for 6 months in the eye with BK. They will be dosed for the first time in the clinic in order to show them how to consistently use the drops. Subjects will also be given a diary card to record potential adverse events and pain levels (with the first level being noted in the clinic), dismissed from the clinic and reminded to return on Day 7 for assessment of tolerability and safety.
At each subsequent visit (Days 7, 60, 120, 180) the subject will be asked to rate their pain at the time of the visit on a pain analog scale. Their diary card will be reviewed for potential adverse events (AEs) and use of EED will be assessed for technique and compliance. Between visits, subjects will be called every 4 weeks by a member of the study site team to assess potential AEs and dosing compliance.
Additionally, the subject or their caregiver will check the treated eye on a weekly basis and note whether the calcific bands are still present on the diary card. When bands have disappeared, subject will notify the eye clinic and schedule a return visit to obtain corneal photographs and visual acuity test. This may occur outside the planned study visits.
On Day 180, subjects will present at the clinic to return their diary card and unused study product. They will be asked to return to the clinic on Days 270 and 360 for assessment of their visual acuity, pain, corneal photography of the affected eye and potential AEs.
Day 360 will be considered the end of study phase 1. Phase 2 of the study includes long term follow up for possible recurrence. Subjects will be scheduled to return for follow-up visits at months 18 and 24 for assessment of visual acuity and recurrence of BK symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drops Used | Experimental | Drug: EDTA Eye Drops |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDTA Eye DropsOne drop in the Band Keratopathy affected eye only, two times per day for six months. | Drug | Drops Used |
Primary outcome
Changes of the Cornea
Time frame: Days 1, 120 and 180 after the start of the study.
Photographs will be full, direct views taken with a Zeiss model 450 plus split lamp camera.
Change in Snellen Visual Acuity
Time frame: Days 1, 7, 60, 120 and 180 after the start of the study.
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.
Change in the Symptoms Associated with Band Keratopathy
Time frame: Days 1, 7, 60, 180, 270, 360, 540 and 720 after the start of the study.
Evaluation of pain, as rated by the subject on a visual analog scale, will be the primary symptom assessed throughout this study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EDTA Eye Drops in people with Corneal Dystrophy, Band-Shaped, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the Cornea (time frame: Days 1, 120 and 180 after the start of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.