The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
Ophthalmic Research Associates
Andover, Massachusetts, United States
Ophthalmic Research Associates
North Andover, Massachusetts, United States
Sign: Corneal fluorescein staining after CAE exposure at Visit 5
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Time frame: Visit 5 (Day 7 ± 2 Days)
Symptom: Ocular discomfort during CAE exposure at Visit 5
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
Time frame: Visit 5 (Day 7 ± 2 Days)
Sign: Fluorescein staining at each visit over 3 weeks
Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks
Time frame: 7 visits / 3 weeks
Symptom: Ocular discomfort pre and post CAE
Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)
Time frame: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)
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