A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis

Inclusion Criteria:

- Subject capable of giving informed consent and if not, an acceptable surrogate capable
of giving informed consent on behalf of the subject.

- Diagnosed with a history of herpetic eye disease

- Three or more episodes of HSV keratitis based on medical record documentation of
episodes with infectious epithelial keratitis, immune stromal keratitis with or
without epithelial ulceration, endothelitis, or iridocyclitis.

- Prior history of HSV keratitis based on medical record documentation of episode of
infectious epithelial keratitis, immune stromal keratitis with or without epithelial
ulceration, endothelitis, or iridocyclitis and corneal scarring in the central 4mm
zone.

Exclusion Criteria:

- Persons who are pregnant or nursing or intend to become pregnant or nurse in the next
one year.

- Allergy to acyclovir, fluoromethalone, loteprednol, prednisolone acetate, prednisolone
sodium phosphate, or any components of the formulations.

- Persons who are incarcerated.

- Unable to give informed consent or have an acceptable surrogate capable of giving
informed consent on behalf of the subject.

- Persons with systemic medical problems who do not agree to have continued medical
follow-up.

- History of topical corticosteroids to the eyelids or ocular surface of the involved
eye within the prior 30 days prior to enrollment.

- Patients with 3 or more episodes of uveitis in the past 12 months.

- History of keratoplasy or keratorefractive surgery of the involved eye.

- History of open or closed angle glaucoma or ocular hypertension on gtts.

- History of systemic steroid use within the prior 30 days.

- Unable to comply with the study protocol or in the opinion of the investigator would
not be a candidate for participation.

- Persons who are unable to instill gtts despite training/caregiver.