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OpenTrials
Completed

NCT Number: NCT02571556

OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

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)

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Key information

Conditions

Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

About this study

This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and will return to the clinic for examination on Days 1, 14, and 28.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

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

Drug

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

Other names: EGP-437

Primary outcomes

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

    Time frame: Day 14

Secondary outcomes

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

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.