Ocular Graft-versus-host DiseasePhase 2NCT04204122
Vigamox Treatment for Ocular Graft-Versus-Host Disease
A Phase 2 study testing Vigamox in people with Ocular Graft-versus-host Disease, run by Washington University School of Medicine.
Trial summary
In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Graft-versus-host Disease
- What is being tested?
- Vigamox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 31 Mar 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD
Who cannot join
- Treated with antibiotic eye drops in the month prior to enrollment
- History of fluoroquinolone allergy
- Asymmetric ocular disease
- Pregnant
- Nursing
About this study
Official title: Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.
- Conditions
- Ocular Graft-versus-host Disease
- Being tested
- Vigamox, Placebo
- Keywords
- GVHD, Graft-Versus-Host Disease, Ocular Surface, Ocular Surface Microbiome, Vigamox
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigamoxDrug
Also called Moxifloxacin
-FDA approved medication
PlaceboDrug
-The placebo is artificial tear drops
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Eye treated with Vigamox | Experimental | -The participant will be instructed to use one drop from each bottle four times per day for 7 days Receives: Drug: Vigamox |
| Arm 2: Eye treated with placebo | Placebo comparator | -The participant will be instructed to use one drop from each bottle four times per day for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular comfort
- Ocular comfort will be rated by the participant for each eye on a 0-10 Visual Analog Scale
- 0=no discomfort and 10=worst discomfort
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Secondary outcomes (5)
Change in Ocular Surface Disease Index (OSDI) score
- 12 questions with answers ranging from 0=none of the time to 4=all of the time
- The OSDI©is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Visual acuity
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in the Degree of Conjunctival injection
-The degree of conjunctival injection will be graded based on the Validated Bulbar Redness scale
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Corneal/conjunctival punctate epithelial erosions
- The clinical exam will be conducted using the National Eye Institute Fluorescein Staining Scale to grade the degree of corneal and conjunctival stain with a cobalt blue slit lamp filter
- This test divides the cornea into 5 sections. Staining is graded on a scale of 0-3, with 0 indicating absence of staining and 3 indicating severe staining.
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Culture results
-Conjunctival bacterial cultures will be obtained via swab before and after treatment
Measured: First clinic visit through second clinic visit (estimated to be 9-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start15 Jun 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Why it stopped: Investigator decided to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eyes of each enrolled participant will be randomized such that one eye is treated with Vigamox and the other eye is treated with a placebo eye drop.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Margolis, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204122
- Sponsor's protocol ID
- 202003066
- Status last verified
- Aug 2023
- First submitted
- 10 Dec 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT04204122
- Acronym / sponsor ID
- 202003066
- Conditions
- Ocular Graft-versus-host Disease
- Keywords
- GVHD, Graft-Versus-Host Disease, Ocular Surface, Ocular Surface Microbiome, Vigamox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided to close study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 Dec 2019 (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.
In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The eyes of each enrolled participant will be randomized such that one eye is treated with Vigamox and the other eye is treated with a placebo eye drop.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Eye treated with Vigamox | Experimental | Drug: Vigamox-The participant will be instructed to use one drop from each bottle four times per day for 7 days |
| Arm 2: Eye treated with placebo | Placebo comparator | Drug: Placebo-The participant will be instructed to use one drop from each bottle four times per day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD
Key exclusion criteria (5 listed)
- Treated with antibiotic eye drops in the month prior to enrollment
- History of fluoroquinolone allergy
- Asymmetric ocular disease
- Pregnant
- Nursing
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 |
|---|---|---|
| VigamoxAlso: Moxifloxacin-FDA approved medication | Drug | Arm 1: Eye treated with Vigamox |
| Placebo-The placebo is artificial tear drops | Drug | Arm 2: Eye treated with placebo |
Primary outcome
Change in Ocular comfort
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
* Ocular comfort will be rated by the participant for each eye on a 0-10 Visual Analog Scale * 0=no discomfort and 10=worst discomfort
5 secondary outcomes
Change in Ocular Surface Disease Index (OSDI) score
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Visual acuity
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in the Degree of Conjunctival injection
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Corneal/conjunctival punctate epithelial erosions
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Culture results
Time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)
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 8 Aug 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Todd Margolis, M.D., Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vigamox in people with Ocular Graft-versus-host Disease, run by Washington University School of Medicine.
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 1 inclusion and 5 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Ocular comfort (time frame: First clinic visit through second clinic visit (estimated to be 9-14 days)). 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 8 Aug 2023.