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

NCT01602068 | Completed Phase 2 Results

• 1 other identifier: EGP-437-005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Cataract

Keywords

Iontophoresis; Cataract Surgery; Ophthalmology; Posterior Chamber Intraocular Lens Implant

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With AC Cell Count of Zero on Day 7

  Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups

  At Day 7 (plus or minus two days) following the study treatment

Study Arms (2)

Dexamethasone Phosphate Ophthalmic

EXPERIMENTAL

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

100 mM Sodium Citrate Buffer

PLACEBO COMPARATOR

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

Interventions

Dexamethasone Phosphate Ophthalmic DRUG

Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)

Also known as: Active arm, Arm 1

Dexamethasone Phosphate Ophthalmic

100 mM Sodium Citrate Buffer DRUG

Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution

Also known as: In-active control arm, Arm 2

100 mM Sodium Citrate Buffer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyegate Pharmaceuticals, Inc.: lead

Study Sites (3)

Site 501

Miami, Florida, 33176, United States

Location

Site 503

Tamarac, Florida, 33321, United States

Location

Site 502

Washington, Missouri, 63090, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

The surgical procedure eliminates or washes out any remaining study drug product from the ocular tissue which becomes inflamed post-surgery. Exploratory study with multiple efficacy \& safety parameters were evaluated.

Results Point of Contact

• Title: Lisa Brandano
• Organization: Eyegate Pharmaceuticals, Inc.

lbrandano@eyegatepharma.com

781-398-3806

Study Officials

• William Trattler, M.D.

  Center For Excellence In Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 18, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 29, 2019
• Results First Posted: May 21, 2018

Record last verified: 2019-01

Locations

US (3)