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

Dry Eye Syndrome Clinical Trial

Official title:

Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765804
• Other study ID #: EGP-437-002
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2008
• Last updated: August 27, 2010
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2010
• Source: Eyegate Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• EGP-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
• Sodium citrate buffer solution with EyeGate® II System
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates	Andover	Massachusetts
United States	Ophthalmic Research Associates	North Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Secondary	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	7 visits / 3 weeks	Yes
Secondary	Symptom: Ocular discomfort pre and post CAE	Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)	Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)	Yes