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Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL

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ClinicalTrials.gov Identifier: NCT01602068
Recruitment Status : Completed
First Posted : May 18, 2012
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.

Condition or disease Intervention/treatment Phase
Cataract Drug: Dexamethasone Phosphate Ophthalmic Drug: 100 mM Sodium Citrate Buffer Phase 2

Detailed Description:
Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The population studied was comprised of males and females scheduled for unilateral cataract surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0). Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: Dexamethasone Phosphate Ophthalmic
Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
Drug: Dexamethasone Phosphate Ophthalmic
Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Other Name: Active arm, Arm 1

Placebo Comparator: 100 mM Sodium Citrate Buffer
Placebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
Drug: 100 mM Sodium Citrate Buffer
Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution
Other Name: In-active control arm, Arm 2




Primary Outcome Measures :
  1. Proportion of Subjects With AC Cell Count of Zero on Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the study treatment ]
    Proportion of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
  • Male or female 18 years or older
  • Receive, understand, and sign a copy of the written informed consent form
  • Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

  • Subjects not meeting the inclusion criteria
  • Subjects being implanted with a multifocal IOL
  • Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
  • Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
  • Scheduled for surgery in the fellow eye within the study period
  • Have anterior chamber inflammation as measured by slit lamp examination at baseline. Anterior chamber cell and/or flare grade > 0
  • Have used any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to baseline visit
  • Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications
  • Be known corticosteroid intraocular pressure responder in either eye
  • Have used topical corticosteroid or NSAID treatment in either eye ≤ 48 hours prior to baseline visit
  • Systemic administration of corticosteroid within the past 14 days prior to baseline visit
  • Have received intravitreal, sub-Tenon's, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit
  • Have open wounds/ skin disease on the forehead area where the iontophoresis return electrode will be applied
  • Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
  • Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding the placement of the iontophoresis applicator
  • Have significant Fuch's Corneal Dystrophy
  • Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
  • Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin
  • Have optic neuritis of any origin
  • Have clinically suspected or confirmed central nervous system or ocular lymphoma
  • Have active hyphema, pars planitis, choroiditis, Behçet's disease, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
  • Have severe/serious ocular pathology or medical condition which may preclude study completion
  • History of HIV/AIDS
  • Have pacemaker and/or any other electrical sensitive support system
  • Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
  • Have participated in another investigational device or drug study within 30 days of baseline visit
  • Have already participated in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602068


Locations
United States, Florida
Site 501
Miami, Florida, United States, 33176
Site 503
Tamarac, Florida, United States, 33321
United States, Missouri
Site 502
Washington, Missouri, United States, 63090
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
Principal Investigator: William Trattler, M.D. Center For Excellence In Eye Care

Responsible Party: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01602068     History of Changes
Other Study ID Numbers: EGP-437-005
First Posted: May 18, 2012    Key Record Dates
Results First Posted: May 21, 2018
Last Update Posted: May 21, 2018
Last Verified: November 2014

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Cataract Surgery
Ophthalmology
Posterior Chamber Intraocular Lens Implant

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Citric Acid
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents