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

Study 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.

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

Conditions
-----------------
Non-infectious, Non-necrotizing Anterior Scleritis

Intervention / Treatment
-----------------
* Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)
* Drug: Dexamethasone phosphate ophthalmic solution


Participation Criteria
=================
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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment at day 0 and day 7<br>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: Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA | Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)<br>* 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).<br>|
| Active Comparator: Active Treatment at Day 0, Sham Treatment at Day 7<br>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: Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA | Drug: Dexamethasone phosphate ophthalmic solution<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on scleritis scale score |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleritis, anterior scleritis, nodular anterior scleritis, diffuse anterior scleritis