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Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
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.
Details
| Lead sponsor | Eyegate Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 89 |
| Start date | 2008-10 |
| Completion | 2009-02 |
Conditions
- Dry Eye Syndrome
Interventions
- EGP-437 with EyeGate® II System
- Sodium citrate buffer solution with EyeGate® II System
Primary outcomes
- 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.
Countries
United States