Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: EGP-437 with EyeGate® II System; Drug: Sodium citrate buffer solution with EyeGate® II System

• Registration Number: NCT00765804
• Lead Sponsor: Eyegate Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-08
• Disposition First Submitted: 2010-08-20
• Disposition First Submitted QC: 2010-08-20
• Disposition First Posted: 2010-08-25
• Last Update Submitted: 2010-08-27
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose: DP 7.5 mA-min at 2.5 mA	EGP-437 with EyeGate® II System	Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
High Dose: DP 10.5 mA-min at 3.5 mA	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
Placebo: 10.5 mA-min at 3.5 mA	Sodium citrate buffer solution with EyeGate® II System	Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Ophthalmic Research Associates; 🇺🇸 North Andover, Massachusetts, United States