CompletedPhase 1/2

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)

United States80 participantsStarted 2015-11

Plain-language 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)

Who can participate

Age range18 Years – 85 Years

SexALL

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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

What they're measuring

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

Timeframe: Day 14

Trial details

NCT IDNCT02571556

SponsorEyegate Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal trials