Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study

NCT01059955 | Completed Phase 1

• 2 other identifiers: EGP-IST-0011R01FD003910
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief Summary

This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued. Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.

Conditions

Non-infectious, Non-necrotizing Anterior Scleritis

Keywords

scleritis; anterior scleritis; nodular anterior scleritis; diffuse anterior scleritis

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  56 days

Secondary Outcomes (1)

• Improvement on scleritis scale score

  56 days

Study Arms (2)

Active treatment at day 0 and day 7

EXPERIMENTAL

Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and one at Day 7. The three iontophoresis doses are: 1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA 2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA 3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA

Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)

Active Treatment at Day 0, Sham Treatment at Day 7

ACTIVE COMPARATOR

Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and a sham treatment Day 7. The three iontophoresis doses are: 1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA 2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA 3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA

Drug: Dexamethasone phosphate ophthalmic solution

Interventions

Dexamethasone Phosphate Ophthalmic Solution (EGP-437) DRUG

Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only).

Active treatment at day 0 and day 7

Dexamethasone phosphate ophthalmic solution DRUG

Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)

Active Treatment at Day 0, Sham Treatment at Day 7

Eligibility Criteria

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

You may qualify if:

• Male or female age at least 18 years
• A diagnosis of active non-infectious, non-necrotizing anterior scleritis (nodular or diffuse is acceptable)
• Not planning to undergo elective ocular surgery during the study
• Provide written informed consent
• Be able and willing to follow instructions, return for all study visits, and willing to comply with all study-related instructions
• If female and of childbearing potential; submit a urine sample and have a negative pregnancy test at Visit 1; agree to use an acceptable method of contraception during the study. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is post-menopausal (has not had a menstrual cycle for \>2 years or has laboratory evidence of a post-menopausal state). Acceptable methods of contraception include: spermicide with barrier, hormonal contraception, IUD, or surgical sterilization of partner. Complete abstinence throughout the study period also is acceptable.

You may not qualify if:

• Contraindications to the use of the test articles
• Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., corticosteroids)
• For patients not taking systemic corticosteroids or immunosuppressants, any condition constituting conferring a likelihood that systemic corticosteroids or immunosuppressants would need to be started during the 56-day study period
• For patients already taking systemic corticosteroids and/or immunosuppressants, any condition conferring a likelihood that systemic corticosteroid or immunosuppressant dosage would need to be changed during the 56-day study period
• Intraocular pressure high enough that intraocular pressure-lowering medications are likely to be needed (≥25 mmHg or IOP\>target pressure for patients with glaucoma); and/or more than two ocular anti-hypertensive medications (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt or Combigan are considered two medications)
• Glaucoma sufficiently advanced that an intraocular pressure spike would potentially put the patient at substantial risk of vision loss, per the clinician-investigator's judgment.
• Cancer
• Subject is planning to undergo elective surgery during the study period
• Any active ocular infections (bacterial, viral, or fungal), active ocular inflammation other than scleritis (i.e., follicular conjunctivitis, iritis), or preauricular lymphadenopathy
• History or diagnosis of ocular herpes or corneal lesion of suspected herpetic origin
• Severe eyelid or ocular surface lesions impeding application of the iontophoresis applicator
• Severe / serious ocular pathology or medical condition which may preclude study completion
• Any condition conferring a likelihood that topical ophthalmic medications in use at baseline would need to be changed during the 56-day study period.
• History of Stevens-Johnson Syndrome or mucous membrane pemphigoid
• Unwilling to discontinue use of contact lenses for the duration of the study

Sponsors & Collaborators

• John Kempen: lead

Study Sites (6)

University of California, San Francisco

San Francisco, California, United States

Location

University of Miami

Miami, Florida, United States

Location

Wilmer Eye Institute/Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Oregon Health & Sciences University

Portland, Oregon, United States

Location

Scheie Eye Institute/University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• O'Neil EC, Huang J, Suhler EB, Dunn JP Jr, Perez VL, Gritz DC, McWilliams K, Peskin E, Ying GS, Bunya VY, Maguire MG, Kempen JH. Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. Br J Ophthalmol. 2018 Aug;102(8):1011-1013. doi: 10.1136/bjophthalmol-2017-311610. Epub 2018 Apr 17.

  PMID: 29666122 DERIVED

MeSH Terms

Conditions

Scleritis

Condition Hierarchy (Ancestors)

Scleral Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology and Epidemiology

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (6)