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

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