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Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

NCT04598282 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-09-22

No results posted yet for this study

Summary

To prospectively evaluate the effectiveness of Prokera Slim in adults with primary or recurrent herpetic epithelial keratitis in terms of visual function, corneal opacity, time to resolution, cost of care, number of patient visits.

Conditions

  • Herpes Simplex Dendritic Keratitis

Interventions

DEVICE

Prokera Slim

Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.

OTHER

Standard of Care

Standard of care 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).

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Richard Stutzman, M.D. · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2021-10-31
Completion
2022-07-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04598282 on ClinicalTrials.gov