NCT02571556

Brief Summary

To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (IOL)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2015

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

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

October 6, 2015

Last Update Submit

November 29, 2016

Conditions

Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects with an anterior chamber cell count of zero on Day 14

    Day 14

Secondary Outcomes (1)

  • The proportion of subjects with a pain score of zero on Day 7

    Day 7

Study Arms (1)

Dexamethasone Phosphate Ophthalmic Solution

EXPERIMENTAL
Drug: Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA

Interventions

Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mADRUG

Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA

Also known as: EGP-437
Dexamethasone Phosphate Ophthalmic Solution

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have undergone unilateral cataract extraction and implantation of a monofocal IOL at the time of enrollment
  • Age 18 to 85 years
  • 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)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

US(1)