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)

Phase 1

Completed

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

• Registration Number: NCT02571556
• Lead Sponsor: Eyegate Pharmaceuticals, Inc.

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Study Start: 2015-11
• Primary Completion: 2016-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with a pain score of zero on Day 7	Day 7

Trial Locations

Locations (1)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States