Topical Corticosteroid Use in Addition to Oral Antivirals... | NCT03626376

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

NCT03626376

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

Jan 14, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Herpes Simplex Virus Keratitis

Interventions

oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to enroll participants

Expanded Access Info

Start Date

Dec 10, 2019Actual

Primary Completion Date

Mar 2, 2021Estimated

Completion Date

Mar 2, 2022Estimated

First Submitted Date

Aug 8, 2018

First Submission Date that Met QC Criteria

Aug 8, 2018

First Posted Date

Aug 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2021

Last Update Posted Date

Jan 14, 2022Actual

Description Module

Brief Summary

This is a prospective, randomized clinical trial looking to determine the role of prophylactic treatment with topical corticosteroids in preventing recurrences in patients with a history of infectious epithelial keratitis, stromal keratitis,endotheliitis, or iridocyclitis. Patients will be enrolled to one of two treatment arms: Control arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg daily or Study arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	suppressive antiviral treatment	Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
Study Arm	Active Comparator	oral acyclovir or oral valacyclovir	Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily	Drug	Treatment used in standard of care	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of time to first recurrence	Kaplan-Meier curves will be plotted by treatment arm (overall and by site) and 95% confidence intervals for the difference between the time to first recurrences will be estimated. Results will also be plotted by site to provide descriptive summaries of the results.	24 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000212	Acyclovir
C494814	BID protein, human
D000077483	Valacyclovir

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds