Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis
Herpes Simplex Dendritic Keratitis
About this trial
This is an interventional treatment trial for Herpes Simplex Dendritic Keratitis focused on measuring Prokera, Adjunctive Cryopreserved Amniotic Membrane, Prokera Slim
Eligibility Criteria
Inclusion Criteria:
- The subject (male or female) is at least 18 years of age.
- The subject is presenting with primary or recurrent herpetic dendritic epithelial keratitis based on investigator judgement
- The subject is presenting with acute (within 30 days) herpetic dendritic epithelial keratitis
- The subject is willing to comply with all study procedures and is able to consent.
Exclusion Criteria:
- Clinical signs of a cause other than herpes simplex virus
- Presence of corneal ulcer with or without microbial infection
- Lid surface abnormalities or conjunctival scarring that affect lid function in either eye
- Atopic disease
- History of penetrating keratoplasty
- Active stromal keratitis or iritis
- Presence of systemic or ocular infection or inflammation that is not related to herpes simplex virus (such as Sarcoidosis, Cogan syndrome, atopy, Lyme disease, Syphilis, mumps, Epstein-Barr virus)
- Ocular surface malignancy
- History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
- A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
- Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
- Not capable of providing informed consent
Sites / Locations
- Casey Eye Institute, Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Control Arm
Treatment Arm
All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID (four times daily) for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion).
All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion). The treatment arm will also receive the placement of PROKERA SLIM for 5-7 days. A second PROKERA SLIM may be applied based on investigator's discretion. For patients with bilateral involvement only the worse eye will be enrolled for the treatment arm.