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

NCT00765804 | Completed Phase 2

• 1 other identifier: EGP-437-002
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye Syndrome

Keywords

Dry Eye; Iontophoresis; Ophthalmic Delivery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Visit 5 (Day 7 ± 2 Days)

Secondary Outcomes (2)

• Sign: Fluorescein staining at each visit over 3 weeks

  7 visits / 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)

Study Arms (3)

Low Dose: DP 7.5 mA-min at 2.5 mA

ACTIVE COMPARATOR

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

High Dose: DP 10.5 mA-min at 3.5 mA

ACTIVE COMPARATOR

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

Placebo: 10.5 mA-min at 3.5 mA

PLACEBO COMPARATOR

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

Interventions

EGP-437 with EyeGate® II System DRUG

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

High Dose: DP 10.5 mA-min at 3.5 mA; Low Dose: DP 7.5 mA-min at 2.5 mA

Sodium citrate buffer solution with EyeGate® II System DRUG

Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System

Also known as: Sodium citrate buffer solution

Placebo: 10.5 mA-min at 3.5 mA

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyegate Pharmaceuticals, Inc.: lead

Study Sites (2)

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Location

Ophthalmic Research Associates

North Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gail Torkildsen, MD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 31, 2010

Record last verified: 2010-08

Locations

US (2)