Bacterial InfectionsPhase 4NCT00575380
Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
A Phase 4 study testing AzaSite Eye Drops and Vigamox Eye Drops in people with Bacterial Infections and Eye Infections, run by Merck Sharp & Dohme LLC at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections, Eye Infections, Cataract Extraction
- What is being tested?
- AzaSite Eye Drops and Vigamox Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2007to Jun 2008
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
- Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.
Who cannot join
- Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Have a history of ocular pemphigoid.
- Have ever had penetrating ocular surface surgery.
- Have had intraocular surgery within the past 3 months.
- Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
- Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
Show all 15Show fewer
- Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
- Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
- Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
- Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
- Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
- Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
- Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
- Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
- Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Coastal Research Associates, LLC
Atlanta, Georgia, 30339
Medical University of South Carolina
Charleston, South Carolina, 29464
Corona Research Consultants
El Paso, Texas, 79904
Eye Care Specialists
Kingston, Pennsylvania, 18704
Eye Care Arkansas
Little Rock, Arkansas, 72205
Kentuckiana Institute for Eye Research
Louisville, Kentucky, 40207
Center for Excellence in Eye Care
Miami, Florida, 33176
North Valley Eye Medical Group
Mission Hills, California, 91345
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, 29464
Eye Center of North Florida
Panama City, Florida, 32405
Cornea Consultants of Arizone
Phoenix, Arizona, 85032
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11563
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
- Conditions
- Bacterial Infections, Eye Infections, Cataract Extraction
- Being tested
- AzaSite Eye Drops, Vigamox Eye Drops
- Medical subject headings
- Bacterial Infections, Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzaSite Eye DropsDrug
Also called AzaSite (azithromycin ophthalmic solution)
One drop two times a day for two days and once a day for the next five days.
Vigamox Eye DropsDrug
Also called Vigamox(moxifloxacin hydrochloride ophthalmic solution)
One drop three times a day for seven days
| Study group | Role | What they receive |
|---|---|---|
| AzaSite Eye Drops | Active comparator | One drop two times a day for two days and once a day for the next five days Receives: Drug: AzaSite Eye Drops |
| Vigamox Eye Drops | Active comparator | One drop three times a day for seven days Receives: Drug: Vigamox Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Nominal time is scheduled time relative to administration of the first eye drop
Measured: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Secondary outcomes (1)
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Measured: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Reza Haque, MD, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575380
- Sponsor's protocol ID
- 041-103
- Other IDs
- P08655
- Status last verified
- Sep 2011
- First submitted
- 12 Dec 2007
- Last updated
- 22 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.
PubMed 20813346
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery
- ClinicalTrials.gov ID
- NCT00575380
- Acronym / sponsor ID
- 041-103
- Conditions
- Bacterial Infections, Eye Infections, Cataract Extraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Posted 16 Sep 2009
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 evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AzaSite Eye Drops | Active comparator | Drug: AzaSite Eye DropsOne drop two times a day for two days and once a day for the next five days |
| Vigamox Eye Drops | Active comparator | Drug: Vigamox Eye DropsOne drop three times a day for seven days |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
- Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.
Key exclusion criteria (15 listed)
- Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Have a history of ocular pemphigoid.
- Have ever had penetrating ocular surface surgery.
- Have had intraocular surgery within the past 3 months.
- Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
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 |
|---|---|---|
| AzaSite Eye DropsAlso: AzaSite (azithromycin ophthalmic solution)One drop two times a day for two days and once a day for the next five days. | Drug | AzaSite Eye Drops |
| Vigamox Eye DropsAlso: Vigamox(moxifloxacin hydrochloride ophthalmic solution)One drop three times a day for seven days | Drug | Vigamox Eye Drops |
Primary outcome
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Nominal time is scheduled time relative to administration of the first eye drop
1 secondary outcome
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20813346Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.
Related trials for Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
Reza Haque, MD study director
Merck Sharp & Dohme LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AzaSite Eye Drops and Vigamox Eye Drops in people with Bacterial Infections and Eye Infections, run by Merck Sharp & Dohme LLC at 13 sites 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 2 inclusion and 15 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 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Yes. Results are posted in the registry (first posted 16 Sep 2009). 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?
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) (time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312). 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 NCT00575380, which also lists 1 linked publication.
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 22 Sep 2011.