Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
Overview
- Phase
- Phase 1
- Intervention
- Dexamethasone Phosphate Ophthalmic Solution (EGP-437)
- Conditions
- Non-infectious, Non-necrotizing Anterior Scleritis
- Sponsor
- John Kempen
- Enrollment
- 18
- Locations
- 6
- Primary Endpoint
- Dose-limiting toxicity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
John Kempen
Associate Professor of Ophthalmology and Epidemiology
University of Pennsylvania
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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
Arms & Interventions
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: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)
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: Dexamethasone phosphate ophthalmic solution
Outcomes
Primary Outcomes
Dose-limiting toxicity
Time Frame: 56 days
Secondary Outcomes
- Improvement on scleritis scale score(56 days)