Bacterial InfectionsPhase 4NCT00575367

Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

A Phase 4 study testing AzaSite (azithromycin ophthalmic solution) and Vigamox (moxifloxacin hydrochloride ophthalmic solution) in people with Bacterial Infections and Eye Infections, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bacterial Infections, Eye Infections
What is being tested?: AzaSite (azithromycin ophthalmic solution) and Vigamox (moxifloxacin hydrochloride ophthalmic solution)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Oct 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
Have normal lid anatomy.

Who cannot join

Have an abnormal biomicroscopy or ophthalmoscopy exam.
Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
Have used artificial tears in the past thirty days.
Have a diagnosis of on-going ocular infection or lid margin inflammation.
Have ever had penetrating ocular surface or intraocular surgery.
Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.

Show all 13Show fewer

Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
Have had corneal or lid abnormalities.
Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
Have any ocular pathology with the exception of cataracts.
Have a serious systemic disease or uncontrolled medical condition.
Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
Have a history of liver or kidney disease resulting in persisting dysfunction.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai School of Medicine
New York, New York, 10029

Other trials in United States

About this study

Official title: A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Conditions: Bacterial Infections, Eye Infections
Being tested: AzaSite (azithromycin ophthalmic solution), Vigamox (moxifloxacin hydrochloride ophthalmic solution)
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 (azithromycin ophthalmic solution)Drug
One drop ophthalmic solution at Visit 2
Vigamox (moxifloxacin hydrochloride ophthalmic solution)Drug
One drop ophthalmic solution at Visit 2

Study groups in NCT00575367
Study group	Role	What they receive
AzaSite	Active comparator	Not described Receives: Drug: AzaSite (azithromycin ophthalmic solution)
Vigamox	Active comparator	Not described Receives: Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Measured: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Oct 2008

First posted18 Dec 2007 (estimated)
Study startMar 2008
Primary completionOct 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.
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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575367
Sponsor's protocol ID: 041-101
Other IDs: P08653
Status last verified: Sep 2011
First submitted: 14 Dec 2007
Last updated: 22 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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 Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration
ClinicalTrials.gov ID: NCT00575367
Acronym / sponsor ID: 041-101
Conditions: Bacterial Infections, Eye Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Oct 2008 (actual)
First posted: 18 Dec 2007 (estimated)
Results: Posted 17 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 of AzaSite compared to Vigamox in tears of healthy volunteers

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AzaSite	Active comparator	Drug: AzaSite (azithromycin ophthalmic solution)
Vigamox	Active comparator	Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
Have normal lid anatomy.

Key exclusion criteria (13 listed)

Have an abnormal biomicroscopy or ophthalmoscopy exam.
Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
Have used artificial tears in the past thirty days.
Have a diagnosis of on-going ocular infection or lid margin inflammation.
Have ever had penetrating ocular surface or intraocular surgery.

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 (azithromycin ophthalmic solution)One drop ophthalmic solution at Visit 2	Drug	AzaSite
Vigamox (moxifloxacin hydrochloride ophthalmic solution)One drop ophthalmic solution at Visit 2	Drug	Vigamox

Primary outcome

Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Time frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours

Results and safety

Results posted to the registry on 17 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AzaSite	19	19
Vigamox	18	18

Primary outcome: Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.

Time frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. Mean (Standard Deviation). Unit: µg/mL

Measure	AzaSite n = 18	Vigamox n = 17
15 Minutes	16.485 (22.9971)	8.199 (15.9873)
1 Hour	4.007 (4.3680)	2.221 (4.1506)
2 Hours	1.966 (3.6632)	2.985 (5.6350)
4 Hours	1.558 (2.6151)	0.603 (1.0074)
8 Hours	2.590 (4.8111)	1.364 (2.7629)
24 Hours	0.195 (0.2558)	0.021 (0.0449)

Population analysed: Per Protocol Population

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AzaSite	0 of 19 (0%)	0 of 19 (0%)	Not reported
Vigamox	0 of 18 (0%)	0 of 18 (0%)	Not reported

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.

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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.

Reza Haque, MD study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 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?

Yes. Results are posted in the registry (first posted 17 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?

Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. (time frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours). 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 NCT00575367.

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.