A Phase 2 interventional study of EGP-437 with EyeGate® II System and Sodium citrate buffer solution with EyeGate® II System in Dry Eye Syndrome, sponsored by Eyegate Pharmaceuticals, Inc.. Completed at 2 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2010-08-31.
Sponsored by Eyegate Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 89 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Eyegate Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
Drug: EGP-437 with EyeGate® II System
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA
Drug: EGP-437 with EyeGate® II System
Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)
Drug: Sodium citrate buffer solution with EyeGate® II System
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Also known as: Dexamethasone phosphate ophthalmic solution
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
Also known as: Sodium citrate buffer solution
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)
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Eyegate Pharmaceuticals, Inc.