A Pilot Study to Assess the Preliminary Efficacy of EDTA Eye Drops on Band Keratopathy

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Livionex Inc
• Treatments: Ophthalmic Solutions

Criteria

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