NCT02517619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 16, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

August 5, 2015

Last Update Submit

July 24, 2018

Conditions

Anterior Uveitis

Keywords

IontophoresisOphthalmologyNon-Infectious Anterior Segment Uveitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with an AC cell count of zero at Day 14

    Day 14 ± 2 days

Study Arms (2)

Dexamethasone Phosphate Ophthalmic Solution

EXPERIMENTAL

Dexamethasone phosphate ophthalmic solution (40 mg/mL)

Drug: Dexamethasone Phosphate Ophthalmic Solution

Prednisolone Acetate Ophthalmic (1%)

ACTIVE COMPARATOR

Prednisolone Acetate Ophthalmic (1%)

Drug: Prednisolone Acetate Ophthalmic (1%)

Interventions

Dexamethasone Phosphate Ophthalmic SolutionDRUG

40 mg/mL

Also known as: EGP-437
Dexamethasone Phosphate Ophthalmic Solution
Prednisolone Acetate Ophthalmic (1%)DRUG

Prednisolone Acetate (1%)

Also known as: Pred Acetate (1%)
Prednisolone Acetate Ophthalmic (1%)

Eligibility Criteria

Age12 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Uveitis, Anterior

Interventions

prednylidene

Condition Hierarchy (Ancestors)

PanuveitisUveitisUveal DiseasesEye Diseases

Study Officials

  • John D. Sheppard, M.D.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

January 16, 2016

Primary Completion

April 20, 2018

Study Completion

May 29, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Locations

US(1)