Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03985371
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2019-06-07
Brief Title:
A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
An Open-label Pilot Study to Assess the Safety Tolerability and Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 timesday 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
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 timesday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None