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Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

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.
 
ClinicalTrials.gov Identifier: NCT00694135
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

Condition or disease Intervention/treatment Phase
Uveitis, Anterior Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System Phase 2

Detailed Description:
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis
Study Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009


Arm Intervention/treatment
Active Comparator: EGP-437 1.6 mA-min at 0.4 mA
Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution

Active Comparator: EGP-437 4.8 mA-min at 1.2 mA
Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution

Active Comparator: EGP-437 10.0 mA-min at 2.5 mA
Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution

Active Comparator: EGP-437 14.0 mA-min at 3.5 mA
Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution




Primary Outcome Measures :
  1. Proportion of subjects with an ACC score of zero at Days 14 and 28 [ Time Frame: Prospective study, subjects followed for 28 days ]
    Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28


Secondary Outcome Measures :
  1. Time to ACC score of zero [ Time Frame: Prospective study, subjects followed for 28 days ]
    Time to anterior chamber cell score of zero

  2. Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28 [ Time Frame: Prospective study, subjects followed for 28 days ]
    Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28

  3. Change from baseline in ACC score at Day 28 [ Time Frame: Prospective study, subjects followed for 28 days ]
    Change from baseline in anterior chamber cell score at Day 28

  4. Treatment emergent adverse events [ Time Frame: Prospective study, subjects followed for 28 days ]
    Treatment emergent adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Previous anterior uveitis episode ≤ 4 weeks prior to baseline
  • Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
  • Topical corticosteroid treatment in either eye < 48 hours prior to baseline
  • Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
  • Active intermediate or posterior uveitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694135


Locations
Show Show 19 study locations
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
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Principal Investigator: C. Stephen Foster, MD Massachusetts Eye Research and Surgery Institution
Principal Investigator: Michael Raizman, MD Ophthalmic Consultants of Boston

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Responsible Party: Stephen From, President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00694135    
Other Study ID Numbers: EGP-437-001
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010
Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Non-Infectious Acute Anterior Segment Uveitis
Ophthalmology
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Panuveitis
Dexamethasone
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action