Dry Eye Syndrome
Conditions
Keywords
Dry Eye, Iontophoresis, Ophthalmic Delivery
Brief summary
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.
Detailed description
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.
Interventions
DRUGEGP-437 with EyeGate® II System
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
DRUGSodium citrate buffer solution with EyeGate® II System
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
Sponsors
Eyegate Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a reported history of dry eye in each eye * Be at least 12 years of age * Demonstrate a response when exposed to the Controlled Adverse Environment model
Exclusion criteria
* Have contraindications to the use of the test articles * Have known allergy or sensitivity to the study medication or their components (including corticosteroids) * Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy * Be current contact lens wearers or wear contacts during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sign: Corneal fluorescein staining after CAE exposure at Visit 5 | Visit 5 (Day 7 ± 2 Days) | Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale. |
| Symptom: Ocular discomfort during CAE exposure at Visit 5 | Visit 5 (Day 7 ± 2 Days) | Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sign: Fluorescein staining at each visit over 3 weeks | 7 visits / 3 weeks | Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks |
| Symptom: Ocular discomfort pre and post CAE | Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days) | Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5) |
Countries
United States
Outcome results
None listed