Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye - Full Text View

Sponsored by:	Eyegate Pharmaceuticals, Inc.
Information provided by:	Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00765804

Purpose

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.

Condition	Intervention	Phase
Dry Eye Syndrome	Drug: Dexamethasone phosphate ophthalmic solution Drug: Sodium citrate buffer solution	Phase II

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model

Further study details as provided by Eyegate Pharmaceuticals, Inc.:

Primary Outcome Measures:

Sign: Corneal fluorescein staining after CAE exposure, Symptom: Ocular discomfort during CAE exposure [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Signs: Fluorescein staining, Symptoms: Ocular discomfort pre and post chamber [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA	Drug: Dexamethasone phosphate ophthalmic solution Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
2: Active Comparator Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA	Drug: Dexamethasone phosphate ophthalmic solution Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
3: 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 Sodium citrate buffer solution 100 mM

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765804

Contacts

Contact: Amy Cohen	781.398.3834	acohen@eyegatepharma.com
Contact: Jennifer Sugarman	781.788.3803	jsugarman@eyegatepharma.com

Locations

United States, Massachusetts
Ophthalmic Research Associates	Recruiting
Andover, Massachusetts, United States, 01810
Contact: Brooke Nentwig 978-689-0020 bnentwig@oraclinical.com
Principal Investigator: Gail Torkildsen, MD
Ophthalmic Research Associates	Recruiting
North Andover, Massachusetts, United States, 01845
Contact: Brooke Nentwig 978-689-0020 bnentwig@oraclinical.com
Principal Investigator: Gail Torkildsen, MD

Sponsors and Collaborators

Eyegate Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Gail Torkildsen, MD

Ophthalmic Research Associates

More Information

Responsible Party:	Eyegate Pharmaceuticals, Inc. ( Stephen From/Chief Executive Officer )
Study ID Numbers:	EGP-437-002
Study First Received:	October 2, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00765804
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyegate Pharmaceuticals, Inc.:

Dry Eye
Iontophoresis
Ophthalmic Delivery

Study placed in the following topic categories:

Dexamethasone
Eye Diseases
Citric Acid

Lacrimal Apparatus Diseases
Dry Eye Syndromes
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease
Anticoagulants
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics

Hormones
Glucocorticoids
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Syndrome
Therapeutic Uses
Chelating Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009