Bacterial ConjunctivitisPhase 3NCT00105469

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

A Phase 3 study testing AzaSite and Tobramycin in people with Bacterial Conjunctivitis, run by Merck Sharp & Dohme LLC at 26 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Bacterial Conjunctivitis
What is being tested?: AzaSite and Tobramycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 743 participants
Where: 26 sitesUnited States
Study dates: Jul 2004to Oct 2005
Phase: Phase 3
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 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female subject, of any race, who is at least 1 year of age.
Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
Must be willing to discontinue contact lens wear for the duration of the study.

Who cannot join

Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.
Any active upper respiratory tract infection.
Pregnant or nursing females.
Use of any antibiotic (topical or systemic) within 72 hours of enrollment.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Palm Beach Eye Associates
Atlantis, Florida, 33462
Renaissance Center
Birmingham, Alabama, 35205
Jon Fishburn, MD
Boise, Idaho, 83706
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
The Eye Associates
Bradenton, Florida, 34209
Mason Eye Institute
Columbia, Missouri, 65212
Ophthalmology Associates
Creve Coeur, Missouri, 63141
Corona Research Consultants, Inc.
El Paso, Texas, 79904
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
Southern Eye Associates, PA
Greenville, South Carolina, 29605
Cornerstone Eye Care
High Point, North Carolina, 27262
Huntington Medical Group
Huntington Station, New York, 11746
Hutchinson Clinic
Hutchinson, Kansas, 67502
Alan Shuster, MD
Jupiter, Florida, 33458
Research Eye Care Center
Kansas City, Missouri, 64132
Children's Eye Physicians
Littleton, Colorado, 80122
Cottonwood Ophthalmology Associates
Murray, Utah, 84107
Pasco Eye Institute
New Port Richey, Florida, 34652
Tukoi Institute for Clinical Research
North Miami Beach, Florida, 33169
Advanced Eye Care
Panama City, Florida, 32405
Irving Weinberger, MD
Pittsburgh, Pennsylvania, 15228
Eye Health Northwest
Portland, Oregon, 97209
Ophthalmology Associates
Princeton, New Jersey, 08540
Rockwood Clinic, PS-Eye Center
Spokane, Washington, 99205
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
Presidential Eye Center
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

Conditions: Bacterial Conjunctivitis
Being tested: AzaSite, Tobramycin
Keywords: Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection
Medical subject headings: Conjunctivitis, Bacterial, Conjunctivitis, Eye Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzaSiteDrug
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
TobramycinDrug
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

Study groups in NCT00105469
Study group	Role	What they receive
AzaSite	Experimental	1.0% azithromycin in DuraSite Receives: Drug: AzaSite
Tobramycin	Active comparator	0.3% tobramycin Receives: Drug: Tobramycin

What is being measured

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

Number of Participants Who Achieved Clinical Resolution at Visit 3
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Measured: Visit 3 (Day 6)

Secondary outcomes (1)

Number of Participants Who Achieved Bacterial Eradication at Visit 3
Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).
Measured: Visit 3 (Day 6)

Timeline

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

Jul 2004Oct 2005

First posted15 Mar 2005 (estimated)
Study startJul 2004
Primary completionOct 2005
Study completionOct 2005

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 ConjunctivitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105469
Sponsor's protocol ID: P08633
Other IDs: C-01-401-004
Status last verified: Nov 2013
First submitted: 14 Mar 2005
Last updated: 16 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.
PubMed 17652708

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?

See locations

Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases

All Bacterial Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis
ClinicalTrials.gov ID: NCT00105469
Acronym / sponsor ID: P08633
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 743 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 15 Mar 2005 (estimated)
Results: Posted 27 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AzaSite	Experimental	Drug: AzaSite1.0% azithromycin in DuraSite
Tobramycin	Active comparator	Drug: Tobramycin0.3% tobramycin

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Male or female subject, of any race, who is at least 1 year of age.
Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
Must be willing to discontinue contact lens wear for the duration of the study.

Key exclusion criteria (6 listed)

Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.
Any active upper respiratory tract infection.
Pregnant or nursing females.

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
AzaSiteAzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.	Drug	AzaSite
TobramycinTobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.	Drug	Tobramycin

Primary outcome

Number of Participants Who Achieved Clinical Resolution at Visit 3
Time frame: Visit 3 (Day 6)
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).

1 secondary outcome

Number of Participants Who Achieved Bacterial Eradication at Visit 3
Time frame: Visit 3 (Day 6)

Results and safety

Results posted to the registry on 27 Oct 2011, 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	365	343
Tobramycin	378	367

Primary outcome: Number of Participants Who Achieved Clinical Resolution at Visit 3

Time frame: Visit 3 (Day 6). Number. Unit: Participants

Measure	AzaSite n = 159	Tobramycin n = 157
Value	127	123

Population analysed: Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AzaSite	0 of 365 (0%)	0 of 365 (0%)	Not reported
Tobramycin	0 of 378 (0%)	0 of 378 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 17652708Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.
Related InfoLink provided by the sponsor.

Related trials for Bacterial Conjunctivitis

Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AzaSite and Tobramycin in people with Bacterial Conjunctivitis, run by Merck Sharp & Dohme LLC at 26 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 4 inclusion and 6 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Oct 2011). 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?

Number of Participants Who Achieved Clinical Resolution at Visit 3 (time frame: Visit 3 (Day 6)). 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 NCT00105469, 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 16 Dec 2013.