Eye InfectionPhase 4NCT00347828
Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose
A Phase 4 study testing Moxifloxacin ophthalmic solution 0.5% and Gatifloxacin ophthalmic solution 0.3% in people with Eye Infection and Infection, run by Ophthalmic Consultants of Boston at 1 site in United States.
Trial summary
The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Infection, Infection
- What is being tested?
- Moxifloxacin ophthalmic solution 0.5% and Gatifloxacin ophthalmic solution 0.3%
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2006
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 25 years of age or older
- Informed consent
- Likely to complete the entire course of the study
Who cannot join
- Contraindications or known sensitivity to any component of the study medications
- A subject on oral or topical antibiotics
- A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
- Monocular subjects
- Contact lens wearers
- Subjects who regularly take eyedrops other than preservative free artificial tears
- A subject with an eye infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
About this study
Official title: Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose
The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.
Read the detailed description
Topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. These bacteria serve as potential sources for post-operative infection. One commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. Studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the Zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic Vigamox, which does not include this preservative.
Comparison: The effect of Zymar antibiotic eye drops on conjunctival cultures compared to the effect of Vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.
- Conditions
- Eye Infection, Infection
- Being tested
- Moxifloxacin ophthalmic solution 0.5%, Gatifloxacin ophthalmic solution 0.3%
- Keywords
- Antibiotic prophylaxis, Vigamox, Moxifloxacin, Zymar, Gatifloxacin, Preoperative antibiotic, Eye infection
- Medical subject headings
- Eye Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin ophthalmic solution 0.5%Drug
Gatifloxacin ophthalmic solution 0.3%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Boston
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Michael B Raizman, B.A./M.D., Principal investigator, Ophthalmic Consultants of BostonSandra Y Cho, B.A./M.D., Study director, New England Eye Center/Tufts-New England Medical CenterRahul Mandiga, B.S., Study director, New England Eye Center/Tufts-New England Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347828
- Sponsor's protocol ID
- Allergan/Z101
- Status last verified
- Jun 2006
- First submitted
- 30 Jun 2006
- Last updated
- 4 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose
- ClinicalTrials.gov ID
- NCT00347828
- Acronym / sponsor ID
- Allergan/Z101
- Conditions
- Eye Infection, Infection
- Keywords
- Antibiotic prophylaxis, Vigamox, Moxifloxacin, Zymar, Gatifloxacin, Preoperative antibiotic, Eye infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Ophthalmic Consultants of BostonUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2006
- Study completion
- Jun 2006
- First posted
- 4 Jul 2006 (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 purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.
Detailed description
Topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. These bacteria serve as potential sources for post-operative infection. One commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. Studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the Zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic Vigamox, which does not include this preservative.
Comparison: The effect of Zymar antibiotic eye drops on conjunctival cultures compared to the effect of Vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 25 years of age or older
- Informed consent
- Likely to complete the entire course of the study
Key exclusion criteria (7 listed)
- Contraindications or known sensitivity to any component of the study medications
- A subject on oral or topical antibiotics
- A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
- Monocular subjects
- Contact lens wearers
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 |
|---|---|---|
| Moxifloxacin ophthalmic solution 0.5% | Drug | – |
| Gatifloxacin ophthalmic solution 0.3% | Drug | – |
Primary outcome
Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2006.
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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.
Michael B Raizman, B.A./M.D. principal investigator
Ophthalmic Consultants of Boston
Sandra Y Cho, B.A./M.D. study director
New England Eye Center/Tufts-New England Medical Center
Rahul Mandiga, B.S. study director
New England Eye Center/Tufts-New England Medical Center
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 Moxifloxacin ophthalmic solution 0.5% and Gatifloxacin ophthalmic solution 0.3% in people with Eye Infection and Infection, run by Ophthalmic Consultants of Boston 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Jul 2006. 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 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?
Results are not available in the source record.
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?
Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs. The study lists 4 primary outcomes in all. 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 4 Jul 2006.