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 range18 Years – 85 Years

SexALL

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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
✕. The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
✕. Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
✕. Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
✕. Have undergone cataract surgery in the fellow eye within 4 weeks prior to baseline visit (Day 0) and still require post-operative medications in that fellow eye
✕. Are scheduled for surgery in the fellow eye within the study period
✕. Have anterior chamber inflammation as measured by slit lamp examination in the study eye at the baseline visit (Day 0) \[Defined as anterior chamber (AC) cell and/or flare grade \> 0\]

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