A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy
Condition: Corneal Dystrophy, Band-Shaped
MeSH terms: Corneal Dystrophies, Hereditary
Study type: Interventional
Phase: Early Phase 1

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
      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.
    

Intervention name(s): EDTA Eye Drops
Intervention type(s): Drug
Intervention description(s): One drop in the Band Keratopathy affected eye only, two times per day for six months.
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Band Keratopathy