Conjunctical FloraNCT00466570
Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour Application
A study testing gatifloxacin, moxifloxacin in people with Conjunctical Flora, run by Stanford University.
Trial summary
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Conjunctical Flora
- What is being tested?
- gatifloxacin, moxifloxacin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to not given
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age- older than 50 years of age
- Diagnosis- Cataract or had cataract surgery
Who cannot join
- Systemic or topical antibiotic treatment within 30 days
- Use of systemic or topical steroids
- Active ocular infection
- Ocular surgery in the past 6 months
- Allergy to fluoroquinolones
About this study
Official title: Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.
- Conditions
- Conjunctical Flora
- Being tested
- gatifloxacin, moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gatifloxacin, moxifloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic killing of conjunctival bacterial flora 1 hour after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Conjunctical FloraStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ta, Stanford University
- Investigators
- Christopher Ta, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466570
- Sponsor's protocol ID
- 8924
- Status last verified
- Jun 2013
- First submitted
- 25 Apr 2007
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ta CN, He L, Nguyen E, De Kaspar HM. Prospective randomized study determining whether a 3-day application of ofloxacin results in the selection of fluoroquinolone-resistant coagulase-negative Staphylococcus. Eur J Ophthalmol. 2006 May-Jun;16(3):359-64.
PubMed 16761235Mino de Kaspar H, Koss MJ, He L, Blumenkranz MS, Ta CN. Antibiotic susceptibility of preoperative normal conjunctival bacteria. Am J Ophthalmol. 2005 Apr;139(4):730-3. doi: 10.1016/j.ajo.2004.10.007.
PubMed 15808182de Kaspar HM, Kreidl KO, Singh K, Ta CN. Comparison of preoperative conjunctival bacterial flora in patients undergoing glaucoma or cataract surgery. J Glaucoma. 2004 Dec;13(6):507-9. doi: 10.1097/01.ijg.0000137872.19942.cf.
PubMed 15534478Ta CN, Chang RT, Singh K, Egbert PR, Shriver EM, Blumenkranz MS, Mino de Kaspar H. Antibiotic resistance patterns of ocular bacterial flora: a prospective study of patients undergoing anterior segment surgery. Ophthalmology. 2003 Oct;110(10):1946-51. doi: 10.1016/s0161-6420(03)00735-8.
PubMed 14522770Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.
PubMed 12414411
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour
- ClinicalTrials.gov ID
- NCT00466570
- Acronym / sponsor ID
- 8924
- Conditions
- Conjunctical Flora
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 27 Apr 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.
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age- older than 50 years of age
- Diagnosis- Cataract or had cataract surgery
Key exclusion criteria (5 listed)
- Systemic or topical antibiotic treatment within 30 days
- Use of systemic or topical steroids
- Active ocular infection
- Ocular surgery in the past 6 months
- Allergy to fluoroquinolones
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, moxifloxacin | Drug | – |
Primary outcome
Antibiotic killing of conjunctival bacterial flora 1 hour after application
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 13 Jun 2013.
- Background: PubMed 16761235Ta CN, He L, Nguyen E, De Kaspar HM. Prospective randomized study determining whether a 3-day application of ofloxacin results in the selection of fluoroquinolone-resistant coagulase-negative Staphylococcus. Eur J Ophthalmol. 2006 May-Jun;16(3):359-64.
- Background: PubMed 15808182Mino de Kaspar H, Koss MJ, He L, Blumenkranz MS, Ta CN. Antibiotic susceptibility of preoperative normal conjunctival bacteria. Am J Ophthalmol. 2005 Apr;139(4):730-3. doi: 10.1016/j.ajo.2004.10.007.
- Background: PubMed 15534478de Kaspar HM, Kreidl KO, Singh K, Ta CN. Comparison of preoperative conjunctival bacterial flora in patients undergoing glaucoma or cataract surgery. J Glaucoma. 2004 Dec;13(6):507-9. doi: 10.1097/01.ijg.0000137872.19942.cf.
- Background: PubMed 14522770Ta CN, Chang RT, Singh K, Egbert PR, Shriver EM, Blumenkranz MS, Mino de Kaspar H. Antibiotic resistance patterns of ocular bacterial flora: a prospective study of patients undergoing anterior segment surgery. Ophthalmology. 2003 Oct;110(10):1946-51. doi: 10.1016/s0161-6420(03)00735-8.
- Background: PubMed 12414411Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.
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.
Christopher Ta, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing gatifloxacin, moxifloxacin in people with Conjunctical Flora, run by Stanford University.
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 2 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 13 Jun 2013. 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 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?
Antibiotic killing of conjunctival bacterial flora 1 hour after application. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466570, which also lists 5 linked publications.
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 Jun 2013.