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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Kempen, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01059955
First received: January 28, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Non-infectious, Non-necrotizing Anterior Scleritis
Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)
Drug: Dexamethasone phosphate ophthalmic solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement on scleritis scale score [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment at day 0 and day 7

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)
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 Comparator: Active Treatment at Day 0, Sham Treatment at Day 7

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
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age at least 18 years
  2. A diagnosis of active non-infectious, non-necrotizing anterior scleritis (nodular or diffuse is acceptable)
  3. Not planning to undergo elective ocular surgery during the study
  4. Provide written informed consent
  5. Be able and willing to follow instructions, return for all study visits, and willing to comply with all study-related instructions
  6. 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.

Exclusion Criteria:

  1. Contraindications to the use of the test articles
  2. Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., corticosteroids)
  3. 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
  4. 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
  5. 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)
  6. 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.
  7. Cancer
  8. Subject is planning to undergo elective surgery during the study period
  9. Any active ocular infections (bacterial, viral, or fungal), active ocular inflammation other than scleritis (i.e., follicular conjunctivitis, iritis), or preauricular lymphadenopathy
  10. History or diagnosis of ocular herpes or corneal lesion of suspected herpetic origin
  11. Severe eyelid or ocular surface lesions impeding application of the iontophoresis applicator
  12. Severe / serious ocular pathology or medical condition which may preclude study completion
  13. Any condition conferring a likelihood that topical ophthalmic medications in use at baseline would need to be changed during the 56-day study period.
  14. History of Stevens-Johnson Syndrome or mucous membrane pemphigoid
  15. Unwilling to discontinue use of contact lenses for the duration of the study
  16. Any open wounds / skin disease on the forehead where the iontophoresis return electrode will be applied
  17. Pacemakers and/or any other electrical sensitive support system
  18. Any significant illness or condition that could, in the investigator's or sub-investigator's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk
  19. Be currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
  20. Participation in an investigational drug or device study within 30 days of entering the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059955

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States
United States, Florida
University of Miami
Miami, Florida, United States
United States, Maryland
Wilmer Eye Institute/Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, New York
Montefiore Medical Center
Bronx, New York, United States
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States
United States, Pennsylvania
Scheie Eye Institute/University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
John Kempen
  More Information

No publications provided

Responsible Party: John Kempen, Associate Professor of Ophthalmology and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01059955     History of Changes
Other Study ID Numbers: EGP-IST-001, 1R01FD003910
Study First Received: January 28, 2010
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
scleritis
anterior scleritis
nodular anterior scleritis
diffuse anterior scleritis

Additional relevant MeSH terms:
Scleritis
Scleral Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014