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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)

Sponsor
Eyegate Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02571556
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
12
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone Phosphate Ophthalmic Solution

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
Other Names:
  • EGP-437

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects with an anterior chamber cell count of zero on Day 14 [Day 14]

    Secondary Outcome Measures

    1. The proportion of subjects with a pain score of zero on Day 7 [Day 7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Eyegate Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eyegate Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02571556
    Other Study ID Numbers:
    • EGP-437-008
    First Posted:
    Oct 8, 2015
    Last Update Posted:
    Nov 30, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Cataract
    Dexamethasone
    Ophthalmic Solutions
    Dexamethasone 21-phosphate

    Study Results

    No Results Posted as of Nov 30, 2016