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)

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02571556

EGP-437-008

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Dexamethasone Phosphate Ophthalmic Solution

Experimental group

Treatment:

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