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)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:12/1/2016
Start Date:November 2015
End Date:November 2016

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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)

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.

Inclusion Criteria:

1. Have undergone unilateral cataract extraction and implantation of a monofocal IOL at
the time of enrollment

2. Age 18 to 85 years

3. Receive, understand, and sign a copy of the written informed consent form

4. Be able to return for all study visits and willing to comply with all study-related
instructions

Exclusion Criteria:
We found this trial at
1
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Boston, Massachusetts 02114
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