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NCT02571556 Clinical Trial

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)

Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02571556
Other study ID # EGP-437-008
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 6, 2015
Last updated November 29, 2016
Start date November 2015
Est. completion date November 2016

Study information
Verified date November 2016
Source Eyegate Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations
Country Name City State
United States Ophthalmic Consultants of Boston Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of subjects with an anterior chamber cell count of zero on Day 14 Day 14 No
Secondary The proportion of subjects with a pain score of zero on Day 7 Day 7 No