- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01602068
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
January 10, 2019 updated by: Eyegate Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33176
- Site 501
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Tamarac, Florida, United States, 33321
- Site 503
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Missouri
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Washington, Missouri, United States, 63090
- Site 502
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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)
|
Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Other Names:
|
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)
|
Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage 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
|
Percentage 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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At Day 7 (plus or minus two days) following the study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Trattler, M.D., Center for Excellence in Eye Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 16, 2012
First Posted (Estimate)
May 18, 2012
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 10, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lens Diseases
- Cataract
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Dexamethasone
- Dexamethasone 21-phosphate
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- EGP-437-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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