Herpes Simplex Virus KeratitisPhase 4NCT03626376
Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
A Phase 4 study testing oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily and oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops in people with Herpes Simplex Virus Keratitis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Herpes Simplex Virus Keratitis
- What is being tested?
- oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily and oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 2 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
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.
- Conditions
- Herpes Simplex Virus Keratitis
- Being tested
- oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily, oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdailyDrug
Treatment used in standard of care
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye dropsDrug
Topical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%. The choice of formulation will be dependent on physician preference and medication availability. Formulations of other potencies such as Difluprednate emulsion will not be used in this study. Patients in the study arm will be started on topical corticosteroid 1 drop once a day in the affected eye.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | suppressive antiviral treatment Receives: Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily |
| Study Arm | Active comparator | oral acyclovir or oral valacyclovir Receives: Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start10 Dec 2019
- Primary completion2 Mar 2021 (estimated)
- Study completion2 Mar 2022 (estimated)
Why it stopped: Unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Virus KeratitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626376
- Sponsor's protocol ID
- 17-01134
- Status last verified
- Dec 2021
- First submitted
- 8 Aug 2018
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
- ClinicalTrials.gov ID
- NCT03626376
- Acronym / sponsor ID
- 17-01134
- Conditions
- Herpes Simplex Virus Keratitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 2 Mar 2022 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdailysuppressive antiviral treatment |
| Study Arm | Active comparator | Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye dropsoral acyclovir or oral valacyclovir |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral acyclovir 400 mg BID OR valacyclovir 500 mg qdailyTreatment used in standard of care | Drug | Control |
| oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye dropsTopical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%. The choice of formulation will be dependent on physician preference and medication availability. Formulations of other potencies such as Difluprednate emulsion will not be used in this study. Patients in the study arm will be started on topical corticosteroid 1 drop once a day in the affected eye. | Drug | Study Arm |
Primary outcome
Measure of time to first recurrence
Time frame: 24 Months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily and oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops in people with Herpes Simplex Virus Keratitis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of time to first recurrence (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.