CompletedPhase 2

Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

United States101 participantsStarted 2017-07-26

Plain-language summary

Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Undergoing 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 (ICF)
. Are able to return for all study visits and willing to comply with all study-related instructions

Exclusion criteria

. Are undergoing implantation of a multifocal and/or depth enhancing IOL
. Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AC cell count = 0

Timeframe: 7 days' following first study treatment

Pain score = 0

Timeframe: 1 day post-surgery and following first study treatment

Trial details

NCT IDNCT03180255

SponsorEyegate Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-07

View on ClinicalTrials.gov More Cataract trials