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

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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.

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.

Condition or disease Intervention/treatment Phase
Anterior Uveitis Drug: Dexamethasone Phosphate Ophthalmic Solution Drug: Prednisolone Acetate Ophthalmic (1%) Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 251 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, 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
Actual Study Start Date : January 16, 2016
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : May 29, 2018


Arm Intervention/treatment
Experimental: Dexamethasone Phosphate Ophthalmic Solution
Dexamethasone phosphate ophthalmic solution (40 mg/mL)
Drug: Dexamethasone Phosphate Ophthalmic Solution
40 mg/mL
Other Name: EGP-437

Active Comparator: Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate Ophthalmic (1%)
Drug: Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate (1%)
Other Name: Pred Acetate (1%)




Primary Outcome Measures :
  1. Proportion of subjects with an AC cell count of zero at Day 14 [ Time Frame: Day 14 ± 2 days ]


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:

  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:


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): NCT02517619


Locations
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
Principal Investigator: John D. Sheppard, M.D. Study Principal Investigator

Responsible Party: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02517619     History of Changes
Other Study ID Numbers: EGP-437-006
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Ophthalmology
Non-Infectious Anterior Segment Uveitis

Additional relevant MeSH terms:
Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Pharmaceutical Solutions
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Dexamethasone 21-phosphate
BB 1101
Ophthalmic Solutions
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