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

January 28, 2010
February 19, 2014
January 2012
February 2014   (final data collection date for primary outcome measure)
Dose-limiting toxicity [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
Dose-limiting toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01059955 on ClinicalTrials.gov Archive Site
Improvement on scleritis scale score [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Improvement on scleritis scale score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-infectious, Non-necrotizing Anterior Scleritis
  • 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).
  • 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)
  • 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
    Intervention: Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)
  • 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
    Intervention: Drug: Dexamethasone phosphate ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059955
EGP-IST-001, 1R01FD003910
No
John Kempen, University of Pennsylvania
John Kempen
Not Provided
Not Provided
University of Pennsylvania
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP