Corneal Epithelial Wound HealingNCT00569881
Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK
An observational study of Corneal Epithelial Wound Healing, run by Donnenfeld, Eric, M.D..
Trial summary
The prescribed antibiotic for prophylaxis of infection following PRK should be effective at eradicating a potential infection. In addition, the antibiotic should have a rapid onset of action, effectively penetrate the target tissue, and be safe and not toxic to any layer of the healing cornea, especially the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Wound Healing
- What is being tested?
- gatifloxacin and moxifloxacin
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 2007
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presented to the practice of a cornea trained ophthalmic consultant.
Who may be able to join
- Patients were eligible for inclusion if they were a healthy male or female 18 years of age or older and were candidates for bilateral PRK.
- Eligible patients had a best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/30 or better in each eye, had a stable prescription for 1 year, were willing to participate in the study, and were able to comprehend and sign the informed consent form.
- All subjects were instructed that if they decide not to participate they could withdraw from the study at any time.
Who cannot join
- Patients were excluded from the study if they had a history of refractive or other ocular surgery in either eye.
- Patients with any condition which could delay wound healing were not eligible to participate.
- They were excluded if they had poor tolerance to any component of the masked study fluoroquinolones, Acular® LS (Allergan) or Pred Forte® (Allergan).
- Patients were also excluded if they required the use of a systemic antibiotic during the study period, were involved in another investigational study or had participated in a study within 30 days prior to the start of this study.
About this study
Official title: Effect of Gatifloxacin 0.3% and Moxifloxacin 0.5% on Epithelial Wound Healing After Photorefractive Keratectomy
The prescribed antibiotic for prophylaxis of infection following PRK should be effective at eradicating a potential infection. In addition, the antibiotic should have a rapid onset of action, effectively penetrate the target tissue, and be safe and not toxic to any layer of the healing cornea, especially the epithelium. Several studies have investigated the toxicity of the fourth generation fluoroquinolones on the corneal epithelium and studies have demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin. Most of these studies, however, have been conducted in animals. This was a retrospective chart review.
Read the detailed description
Prior generation fluoroquinolones predominantly either inhibit topoisomerase II (DNA Gyrase) or topoisomerase IV and therefore only require one genetic mutation for bacteria to develop resistance. Fourth-generation fluoroquinolones are equally effective against topoisomerase II and IV, which significantly expands their spectrum of action against gram-positive agents and atypical mycobacteria and Nocardia . This duality of action of the fourth generation fluoroquinolones requires that for bacteria to become resistant to these agents, the bacteria must undergo two genetic mutations resulting in a significantly decreased chance of an organism developing resistance.Minimum inhibitory concentrations determined in vitro suggest that fourth-generation fluoroquinolones are more effective than second- and third-generation fluoroquinolones against gram-positive bacteria including Staphylococcal species found in endophthalmitis and bacterial keratitis cultures. The increased efficacy of fourth-generation fluoroquinolones make these antibiotics important agents to evaluate for prophylaxis against post-PRK infections. This was a retrospective chart review.
- Conditions
- Corneal Epithelial Wound Healing
- Being tested
- gatifloxacin and moxifloxacin
- Keywords
- Epithelium, Wound Healing, PRK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gatifloxacin and moxifloxacinDrug
Also called Zymar and Vigamox
Comparison of wound healing between drugs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Corneal epithelial wound healing with moxifloxacin Receives: Drug: gatifloxacin and moxifloxacin | |
| 2 | Corneal epithelial wound healing with gatifloxacin Receives: Drug: gatifloxacin and moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Measured: Days after PRK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial Wound HealingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donnenfeld, Eric, M.D.
- Investigators
- Eric Donnenfeld, MD, Principal investigator, OCLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569881
- Sponsor's protocol ID
- Donnenfeld2
- Status last verified
- Dec 2007
- First submitted
- 6 Dec 2007
- Last updated
- 10 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gatifloxacin 0.3% and Moxifloxacin 0.5% on Epithelial Wound Healing After Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT00569881
- Acronym / sponsor ID
- Donnenfeld2
- Conditions
- Corneal Epithelial Wound Healing
- Keywords
- Epithelium, Wound Healing, PRK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Donnenfeld, Eric, M.D.
- Study start
- Jan 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Dec 2007 (estimated)
- 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.
The prescribed antibiotic for prophylaxis of infection following PRK should be effective at eradicating a potential infection. In addition, the antibiotic should have a rapid onset of action, effectively penetrate the target tissue, and be safe and not toxic to any layer of the healing cornea, especially the epithelium. Several studies have investigated the toxicity of the fourth generation fluoroquinolones on the corneal epithelium and studies have demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin. Most of these studies, however, have been conducted in animals. This was a retrospective chart review.
Detailed description
Prior generation fluoroquinolones predominantly either inhibit topoisomerase II (DNA Gyrase) or topoisomerase IV and therefore only require one genetic mutation for bacteria to develop resistance. Fourth-generation fluoroquinolones are equally effective against topoisomerase II and IV, which significantly expands their spectrum of action against gram-positive agents and atypical mycobacteria and Nocardia . This duality of action of the fourth generation fluoroquinolones requires that for bacteria to become resistant to these agents, the bacteria must undergo two genetic mutations resulting in a significantly decreased chance of an organism developing resistance.Minimum inhibitory concentrations determined in vitro suggest that fourth-generation fluoroquinolones are more effective than second- and third-generation fluoroquinolones against gram-positive bacteria including Staphylococcal species found in endophthalmitis and bacterial keratitis cultures. The increased efficacy of fourth-generation fluoroquinolones make these antibiotics important agents to evaluate for prophylaxis against post-PRK infections. This was a retrospective chart review.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: gatifloxacin and moxifloxacinCorneal epithelial wound healing with moxifloxacin |
| 2 | – | Drug: gatifloxacin and moxifloxacinCorneal epithelial wound healing with gatifloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to the practice of a cornea trained ophthalmic consultant.
Key inclusion criteria (3 listed)
- Patients were eligible for inclusion if they were a healthy male or female 18 years of age or older and were candidates for bilateral PRK.
- Eligible patients had a best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/30 or better in each eye, had a stable prescription for 1 year, were willing to participate in the study, and were able to comprehend and sign the informed consent form.
- All subjects were instructed that if they decide not to participate they could withdraw from the study at any time.
Key exclusion criteria (4 listed)
- Patients were excluded from the study if they had a history of refractive or other ocular surgery in either eye.
- Patients with any condition which could delay wound healing were not eligible to participate.
- They were excluded if they had poor tolerance to any component of the masked study fluoroquinolones, Acular® LS (Allergan) or Pred Forte® (Allergan).
- Patients were also excluded if they required the use of a systemic antibiotic during the study period, were involved in another investigational study or had participated in a study within 30 days prior to the start of this study.
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 |
|---|---|---|
| gatifloxacin and moxifloxacinAlso: Zymar and VigamoxComparison of wound healing between drugs | Drug | 1, 2 |
Primary outcome
Wound Healing
Time frame: Days after PRK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
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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.
Eric Donnenfeld, MD principal investigator
OCLI
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Epithelial Wound Healing, run by Donnenfeld, Eric, M.D..
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Dec 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound Healing (time frame: Days after PRK). 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 10 Dec 2007.