Corneal UlcersPhase 2Eye02NCT01928693
A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.
A Phase 2 study testing Besivance 0.6% Ophthalmic Suspension, Zymaxid 0.5% Ophthalmic Solution and Vigamox 0.5% Ophthalmic Solution in people with Corneal Ulcers, run by Cornea Consultants Of Nashville at 1 site in United States.
Trial summary
This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Corneal Ulcers
- What is being tested?
- Besivance 0.6% Ophthalmic Suspension, Zymaxid 0.5% Ophthalmic Solution and Vigamox 0.5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be between the ages of 18-90 years of age.
- Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
- Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
- Patients must have corneal ulcer present in only one eye.
- Patients must agree not to wear contact lenses while on study.
Who cannot join
- Patients with multifocal ulcers.
- Signs of any other viral or fungal infection.
- Treatment with antibiotics within 14 days of study entry.
- Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
- Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
- Contact lens only with no spectacles available.
Show all 9Show fewer
- Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
- Participation in any investigational study within the past 30 days.
- Pregnant women, minors, or those not able to consent for themselves.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea Consultants of Nashville
Nashville, Tennessee, 37203
About this study
Official title: A Single-site, Single Masked, Prospective Comparison of Three Fluoroquinolone Topical Therapies (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%) in the Treatment of Infectious Corneal Ulcers.
This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.
Read the detailed description
This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.
- Conditions
- Corneal Ulcers
- Being tested
- Besivance 0.6% Ophthalmic Suspension, Zymaxid 0.5% Ophthalmic Solution, Vigamox 0.5% Ophthalmic Solution
- Keywords
- infectious corneal ulcers
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besivance 0.6% Ophthalmic SuspensionDrug
Also called Besifloxacin 0.6% Ophthalmic Suspension
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Zymaxid 0.5% Ophthalmic SolutionDrug
Also called Gatifloxacin 0.5% Ophthalmic Solution
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Vigamox 0.5% Ophthalmic SolutionDrug
Also called Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Besivance 0.6% Ophthalmic Suspension | Active comparator | A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. Receives: Drug: Besivance 0.6% Ophthalmic Suspension |
| Zymaxid 0.5% Ophthalmic Solution | Active comparator | A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. Receives: Drug: Zymaxid 0.5% Ophthalmic Solution |
| Vigamox 0.5% Ophthalmic Solution | Active comparator | A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. Receives: Drug: Vigamox 0.5% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Healing
The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.
Measured: 29 days
Secondary outcomes (1)
Healing Rate
Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: study terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal UlcersStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Consultants Of Nashville
- Sponsor type
- University, hospital or other
- Collaborators
- SCRI Development Innovations, LLC, Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Ira A. Shivitz, M.D., Principal investigator, Cornea Consultants Of Nashville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928693
- Sponsor's protocol ID
- Eye02
- Acronym
- Eye02
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2013
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Single Masked, Prospective Comparison of Three Fluoroquinolone Topical Therapies (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%) in the Treatment of Infectious Corneal Ulcers.
- ClinicalTrials.gov ID
- NCT01928693
- Acronym / sponsor ID
- Eye02 / Eye02
- Conditions
- Corneal Ulcers
- Keywords
- infectious corneal ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cornea Consultants Of NashvilleUniversity, hospital or other
- Collaborators
- SCRI Development Innovations, LLC, Bausch & Lomb Incorporated
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 13 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.
Detailed description
This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Besivance 0.6% Ophthalmic Suspension | Active comparator | Drug: Besivance 0.6% Ophthalmic SuspensionA topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. |
| Zymaxid 0.5% Ophthalmic Solution | Active comparator | Drug: Zymaxid 0.5% Ophthalmic SolutionA topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. |
| Vigamox 0.5% Ophthalmic Solution | Active comparator | Drug: Vigamox 0.5% Ophthalmic SolutionA topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be between the ages of 18-90 years of age.
- Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
- Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
- Patients must have corneal ulcer present in only one eye.
- Patients must agree not to wear contact lenses while on study.
Key exclusion criteria (9 listed)
- Patients with multifocal ulcers.
- Signs of any other viral or fungal infection.
- Treatment with antibiotics within 14 days of study entry.
- Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
- Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
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 |
|---|---|---|
| Besivance 0.6% Ophthalmic SuspensionAlso: Besifloxacin 0.6% Ophthalmic SuspensionDrop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours. | Drug | Besivance 0.6% Ophthalmic Suspension |
| Zymaxid 0.5% Ophthalmic SolutionAlso: Gatifloxacin 0.5% Ophthalmic SolutionDrop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours. | Drug | Zymaxid 0.5% Ophthalmic Solution |
| Vigamox 0.5% Ophthalmic SolutionAlso: Moxifloxacin Hydrochloride 0.5% Ophthalmic SolutionDrop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours. | Drug | Vigamox 0.5% Ophthalmic Solution |
Primary outcome
Complete Healing
Time frame: 29 days
The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.
1 secondary outcome
Healing Rate
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ira A. Shivitz, M.D. principal investigator
Cornea Consultants Of Nashville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Besivance 0.6% Ophthalmic Suspension, Zymaxid 0.5% Ophthalmic Solution and Vigamox 0.5% Ophthalmic Solution in people with Corneal Ulcers, run by Cornea Consultants Of Nashville 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Aug 2015. 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. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Healing (time frame: 29 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 13 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.