Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.

Condition	Intervention	Phase
Cataract	Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution Drug: 100 mM sodium citrate buffer solution	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Dexamethasone Dexamethasone phosphate Sodium citrate Dexamethasone acetate Dexamethasone sodium phosphate

U.S. FDA Resources

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

Primary Outcome Measures:

Proportion of subjects with ACC count of zero on Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of patients with ACC count of zero on Day 7 as compared between the active and placebo groups

Secondary Outcome Measures:

Proportion of subjects with a pain score of zero on Day 3 [ Time Frame: At Day 3 following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with a pain score of zero on Day 3 as compared between the active and placebo groups
Proportion of subjects with an ACC count of zero on Day 1 [ Time Frame: At Day 1 following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an ACC count of zero on Day 1 as compared between the active and placebo groups
Proportion of subjects with an ACC count of zero on Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an ACC count of zero on Day 14 as compared between the active and placebo groups
Proportion of subjects with a pain score of zero on Day 1 [ Time Frame: At Day 1 following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with a pain score of zero on Day 1 as compared between the active and placebo groups
Proportion of subjects with a pain score of zero on Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with a pain score of zero on Day 7 as compared between the active and placebo groups
Proportion of subjects with a pain score of zero on Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with a pain score of zero on Day 14 as compared between the active and placebo groups
Proportion of subjects with a pain score of zero on Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with a pain score of zero on Day 28 as compared between the active and placebo groups
Proportion of subjects with an anterior flare grade of zero on Day 1 [ Time Frame: At Day 1 following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an anterior flare grade of zero on Day 1 as compared between the active and placebo groups
Proportion of subjects with an anterior flare grade of zero on Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an anterior flare grade of zero on Day 7 as compared between the active and placebo groups
Proportion of subjects with an anterior flare grade of zero on Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an anterior flare grade of zero on Day 14 as compared between the active and placebo groups
Proportion of subjects with an anterior flare grade of zero on Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an anterior flare grade of zero on Day 28 as compared between the active and placebo groups
The difference in mean cell grades and flare grades at Day 1 [ Time Frame: At Day 1 following the study treatment ] [ Designated as safety issue: Yes ]
The difference in mean cell grades and flare grades at Day 1 as compared between the active and placebo groups
The difference in mean cell grades and flare grades at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
The difference in mean cell grades and flare grades at Day 7 as compared between the active and placebo groups
The difference in mean cell grades and flare grades at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
The difference in mean cell grades and flare grades at Day 14 as compared between the active and placebo groups
The difference in mean cell grades and flare grades at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
The difference in mean cell grades and flare grades at Day 28 as compared between the active and placebo groups
The difference in pain scores at Days 1 through 28 [ Time Frame: Days 1 through 28 ] [ Designated as safety issue: Yes ]
The difference in pain scores at Days 1 through 28 as compared between the active and placebo groups
Proportion of subjects requiring Rescue Therapy [ Time Frame: Up to 28 Days following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects requiring Rescue Therapy as compared between the active and placebo groups
Proportion of subjects with an ACC count of zero on Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the study treatment ] [ Designated as safety issue: Yes ]
Proportion of subjects with an ACC count of zero on Day 28 as compared between the active and placebo groups
Difference in time to pain score of zero [ Time Frame: Days 1 through 28 ] [ Designated as safety issue: Yes ]
Difference in time of pain score of zero as compared between the active and placebo groups

Enrollment:	42
Study Start Date:	May 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)	Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Placebo Comparator: Iontophoretic Placebo Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)	Drug: 100 mM sodium citrate buffer solution Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
Male or female 18 years or older
Receive, understand, and sign a copy of the written informed consent form
Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

Subjects not meeting the inclusion criteria
Subjects being implanted with a multifocal IOL
Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
Scheduled for surgery in the fellow eye within the study period
Have anterior chamber inflammation as measured by slit lamp examination at baseline. Anterior chamber cell and/or flare grade > 0
Have used any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to baseline visit
Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications
Be known corticosteroid intraocular pressure responder in either eye
Have used topical corticosteroid or NSAID treatment in either eye ≤ 48 hours prior to baseline visit
Systemic administration of corticosteroid within the past 14 days prior to baseline visit
Have received intravitreal, sub-Tenon's, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit
Have open wounds/ skin disease on the forehead area where the iontophoresis return electrode will be applied
Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding the placement of the iontophoresis applicator
Have significant Fuch's Corneal Dystrophy
Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin
Have optic neuritis of any origin
Have clinically suspected or confirmed central nervous system or ocular lymphoma
Have active hyphema, pars planitis, choroiditis, Behçet's disease, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
Have severe/serious ocular pathology or medical condition which may preclude study completion
History of HIV/AIDS
Have pacemaker and/or any other electrical sensitive support system
Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
Have participated in another investigational device or drug study within 30 days of baseline visit
Have already participated in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602068

Locations

United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Logan Ophthalmic Research, LLC
Tamarac, Florida, United States, 33321
United States, Missouri
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090

Sponsors and Collaborators

Eyegate Pharmaceuticals, Inc.

Investigators

Principal Investigator:

William Trattler, M.D.

Center For Excellence In Eye Care

More Information

No publications provided

Responsible Party:	Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01602068 History of Changes
Other Study ID Numbers:	EGP-437-005
Study First Received:	May 16, 2012
Last Updated:	March 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyegate Pharmaceuticals, Inc.:

Iontophoresis
Cataract Surgery
Ophthalmology

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Citric Acid
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013