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

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: EGP-437 with EyeGate® II System; Drug: Sodium citrate buffer solution with EyeGate® II System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765804

EGP-437-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 3 patient groups, including a placebo group

Low Dose: DP 7.5 mA-min at 2.5 mA

Active Comparator group

Description:

Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA

Treatment:

Drug: EGP-437 with EyeGate® II System

High Dose: DP 10.5 mA-min at 3.5 mA

Active Comparator group

Description:

Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA

Treatment:

Drug: EGP-437 with EyeGate® II System

Placebo: 10.5 mA-min at 3.5 mA

Placebo Comparator group

Description:

Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)

Treatment:

Drug: Sodium citrate buffer solution with EyeGate® II System