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Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505088
First Posted: January 6, 2012
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.
January 4, 2012
January 6, 2012
March 29, 2013
December 2011
February 2013   (Final data collection date for primary outcome measure)
Proportion of patients with with ACC count of zero at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
Proportion of patients with ACC count of zero at Day 14
Same as current
Complete list of historical versions of study NCT01505088 on ClinicalTrials.gov Archive Site
  • Proportion of patients with ACC count of zero at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 7
  • Proportion of patients with ACC count of zero at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 28
  • Proportion of patients with ACC count of zero at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of patients with ACC count of zero at Day 56
  • Mean change from baseline in ACC count and score at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 7
  • Mean change from baseline in ACC count and score at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 14
  • Mean change from baseline in ACC count and score at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 28
  • Mean change from baseline in ACC count and score at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 56
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
  • Time to anterior chamber cell count and score of zero [ Time Frame: Up to 56 days (plus or minus seven days) following the first study treatment ]
    Time to anterior chamber cell count and score of zero
  • Proportion of patients with ACC count of zero at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 7
  • Proportion of patients with ACC count of zero at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 28
  • Proportion of patients with ACC count of zero at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of patients with ACC count of zero at Day 56
  • Mean change from baseline in ACC count and score at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 7
  • Mean change from baseline in ACC count and score at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 14
  • Mean change from baseline in ACC count and score at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 28
  • Mean change from baseline in ACC count and score at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 56
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
  • The proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
  • Time to anterior chamber cell count and score of zero [ Time Frame: Up to 56 days (plus or minus seven days) following the first study treatment ]
    Time to anterior chamber cell count and score of zero
Not Provided
Not Provided
 
Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
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 prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it is the most common form of uveitis and accounts for approximately 75% of cases.

In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437 treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without requiring additional treatment; produced low short-term systemic exposure to dexamethasone and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8 mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid mediated effects were observed.

The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anterior Uveitis
  • Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution
    Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
  • Drug: Prednisolone Acetate (1%) Eyedrops
    Prednisolone acetate (1%) eyedrops
  • Drug: 100 mM sodium citrate buffer solution
    Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution
  • Drug: Placebo Eyedrops
    Placebo Eyedrops
    Other Name: Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution
  • 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 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days.
    Interventions:
    • Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution
    • Drug: Placebo Eyedrops
  • Active Comparator: Prednisolone Acetate Ophthalmic Suspension (1%)
    Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days.
    Interventions:
    • Drug: Prednisolone Acetate (1%) Eyedrops
    • Drug: 100 mM sodium citrate buffer solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
March 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber cell count of ≥ 11 cells
  • 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:

  • Have uveitis of infectious etiology
  • Have active intermediate or posterior uveitis
  • Known positive HLA-B27 with a severe (4+) fibrinoid reaction
  • Have previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to baseline visit
  • Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior to baseline visit
  • Have used oral corticosteroid within the past 14 days prior to baseline
  • Have received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to baseline visit
  • Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use of over-the-counter dosages is allowable) or prescribed immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study
  • Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications in the study eye
  • Be known steroid intraocular pressure responders in either eye
  • 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 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, or Behçet's disease
  • Have monocular or BCVA worse than 20/80 in the fellow eye
  • Have optic neuritis of any origin
  • Have clinically suspected or confirmed central nervous system or ocular lymphoma
  • Planning to undergo elective ocular surgery during the study
  • Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
  • Have severe/serious ocular pathology or medical condition which may preclude study completion
  • 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 significant Fuch's Corneal Dystrophy
Sexes Eligible for Study: All
12 Years to 85 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01505088
EGP-437-004
No
Not Provided
Not Provided
Eyegate Pharmaceuticals, Inc.
Eyegate Pharmaceuticals, Inc.
Not Provided
Principal Investigator: John D. Sheppard, M.D. Virginia Eye Consultants
Eyegate Pharmaceuticals, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP