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

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.
• 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
• Any open wounds / skin disease on the forehead where the iontophoresis return electrode will be applied
• Pacemakers and/or any other electrical sensitive support system
• 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
• Be currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
• Participation in an investigational drug or device study within 30 days of entering the study