Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

NCT03180255 | Completed Phase 2 FDA Drug

• 1 other identifier: EGP-437-009
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).

Conditions

Cataract; Anterior Chamber Inflammation; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• AC cell count = 0

  The proportion of subjects with an AC cell count of zero on Day 7

  7 days' following first study treatment

• Pain score = 0

  The proportion of subjects with a pain score of zero on Day 1

  1 day post-surgery and following first study treatment

Study Arms (2)

EGP-437

EXPERIMENTAL

40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA

Combination Product: Dexamethasone phosphate

Placebo

PLACEBO COMPARATOR

100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA

Other: Placebo

Interventions

Dexamethasone phosphate COMBINATION_PRODUCT

Ocular iontophoretic delivery of a steroid

EGP-437

Placebo OTHER

Ocular iontophoretic delivery of a placebo

Also known as: Sodium Citrate Buffer

Placebo

Eligibility Criteria

• Age: 18 Years - 85 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)
• Age 18 to 85 years
• Receive, understand, and sign a copy of the written informed consent form (ICF)
• Are able to return for all study visits and willing to comply with all study-related instructions

You may not qualify if:

• Are undergoing implantation of a multifocal and/or depth enhancing IOL
• Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
• The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
• Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
• Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
• Have undergone cataract surgery in the fellow eye within 4 weeks prior to baseline visit (Day 0) and still require post-operative medications in that fellow eye
• Are scheduled for surgery in the fellow eye within the study period
• Have anterior chamber inflammation as measured by slit lamp examination in the study eye at the baseline visit (Day 0) \[Defined as anterior chamber (AC) cell and/or flare grade \> 0\]
• Have history of uveitis or inflammatory disease in the study eye
• Requires simultaneous supplemental surgery, such as glaucoma procedures or vitrectomy, in the study eye
• Have used any topical ocular medication in either eye, other than tear substitute for dry eye, within the past 2 weeks prior to baseline visit (Day 0)
• Have used topical corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) treatment in either eye \< 48 hours prior to the baseline visit (Day 0) (excluding the use of topical NSAIDs, pre-operatively on Day 0 and administered at the clinic site under the investigator's oversight)
• Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, and/or require ocular anti-hypertensive medications
• Are known corticosteroid IOP responder in study eye
• Have received systemic administration of corticosteroid and/or immunosuppressants within the past 14 days prior to baseline visit (Day 0)

Sponsors & Collaborators

• Eyegate Pharmaceuticals, Inc.: lead

Study Sites (1)

Site 901

Jacksonville, Florida, 32204, United States

Location

MeSH Terms

Conditions

Cataract; Pain, Postoperative

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Lisa Brandano, BS

  VP, Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor, investigator, subject will all be masked to study treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked, randomized, placebo-controlled, multi-center, Phase 2b clinical trial designed to evaluate the efficacy and safety of transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 8, 2017
• Study Start: July 26, 2017
• Primary Completion: November 7, 2017
• Study Completion: November 27, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)