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Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis (EGP-437-006)

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: NCT02517619
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 7, 2015
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE January 16, 2016
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Proportion of subjects with an AC cell count of zero at Day 14 [ Time Frame: Day 14 ± 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anterior Uveitis
Intervention  ICMJE
  • Drug: Dexamethasone Phosphate Ophthalmic Solution
    40 mg/mL
    Other Name: EGP-437
  • Drug: Prednisolone Acetate Ophthalmic (1%)
    Prednisolone Acetate (1%)
    Other Name: Pred Acetate (1%)
Study Arms  ICMJE
  • Experimental: Dexamethasone Phosphate Ophthalmic Solution
    Dexamethasone phosphate ophthalmic solution (40 mg/mL)
    Intervention: Drug: Dexamethasone Phosphate Ophthalmic Solution
  • Active Comparator: Prednisolone Acetate Ophthalmic (1%)
    Prednisolone Acetate Ophthalmic (1%)
    Intervention: Drug: Prednisolone Acetate Ophthalmic (1%)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2018)
251
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
250
Actual Study Completion Date  ICMJE May 29, 2018
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
  2. Receive, understand, and sign a copy of the written informed consent form
  3. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02517619
Other Study ID Numbers  ICMJE EGP-437-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Eyegate Pharmaceuticals, Inc.
Study Sponsor  ICMJE Eyegate Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John D. Sheppard, M.D. Study Principal Investigator
PRS Account Eyegate Pharmaceuticals, Inc.
Verification Date July 2018

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