Bacterial ConjunctivitisPhase 3NCT00759148

Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

A Phase 3 study testing Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% in people with Bacterial Conjunctivitis, run by Alcon Research.

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 safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older. Read more about this study

Who is it for?: Ages 1 month and older
Conditions the study is for: Bacterial Conjunctivitis
What is being tested?: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,179 participants
Where: No sites listed yet
Study dates: Oct 2008to Mar 2010
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 month and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosed with bacterial conjunctivitis in 1 or both eyes;
Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
Agrees to comply with the visit schedule and other requirements of the study;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
Presence of concomitant viral infection;
Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
Infants undergoing treatment for retinopathy of prematurity;
Contact lens wear during the course of the study;

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Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
Use of medications, as specified in the protocol;
Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
Known or suspected allergy or hypersensitivity to fluoroquinolones;
Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
Other protocol-specified exclusion criteria may apply.

About this study

Conditions: Bacterial Conjunctivitis
Being tested: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, Moxifloxacin AF Vehicle
Keywords: pink eye, conjunctivitis, moxifloxacin, fluoroquinolone
Medical subject headings: Conjunctivitis, Bacterial, Conjunctivitis

What participants receive

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

Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%Drug
Eye drops
Moxifloxacin AF VehicleOther
Inactive ingredients used as a placebo for masking purposes

Study groups in NCT00759148
Study group	Role	What they receive
Moxifloxacin AF	Experimental	Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days Receives: Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Vehicle	Placebo comparator	Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days Receives: Other: Moxifloxacin AF Vehicle

What is being measured

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

Clinical Cure at the Day 4 (EOT)/Exit Visit
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Measured: Day 4

Secondary outcomes (1)

Microbiological Success at the Day 4 (EOT)/Exit Visit
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Measured: Day 4

Timeline

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

Oct 2008Mar 2010

First posted25 Sep 2008 (estimated)
Study startOct 2008
Primary completionMar 2010
Study completionMar 2010

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 Alcon ResearchThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00759148
Sponsor's protocol ID: C-07-40
Status last verified: Dec 2017
First submitted: 23 Sep 2008
Last updated: 2 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.
PubMed 21681652

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?

Official record

Not yet recruitingPhase 4
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Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
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All Bacterial Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
ClinicalTrials.gov ID: NCT00759148
Acronym / sponsor ID: C-07-40
Conditions: Bacterial Conjunctivitis
Keywords: pink eye, conjunctivitis, moxifloxacin, fluoroquinolone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,179 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2008 (actual)
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 22 Mar 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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Moxifloxacin AF	Experimental	Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Vehicle	Placebo comparator	Other: Moxifloxacin AF VehicleMoxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosed with bacterial conjunctivitis in 1 or both eyes;
Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
Agrees to comply with the visit schedule and other requirements of the study;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (12 listed)

Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
Presence of concomitant viral infection;
Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
Infants undergoing treatment for retinopathy of prematurity;

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 Alternative Formulation (AF) Ophthalmic Solution 0.5%Eye drops	Drug	Moxifloxacin AF
Moxifloxacin AF VehicleInactive ingredients used as a placebo for masking purposes	Other	Vehicle

Primary outcome

Clinical Cure at the Day 4 (EOT)/Exit Visit
Time frame: Day 4
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.

1 secondary outcome

Microbiological Success at the Day 4 (EOT)/Exit Visit
Time frame: Day 4

Results and safety

Results posted to the registry on 22 Mar 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
Moxifloxacin AF	593	579
Vehicle	586	554

Primary outcome: Clinical Cure at the Day 4 (EOT)/Exit Visit

Time frame: Day 4. Number. Unit: percentage of subjects

Measure	Moxifloxacin AF n = 424	Vehicle n = 423
Value	62.5	50.6

Population analysed: This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline through study completion, an average of 4 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moxifloxacin AF	0 of 593 (0%)	0 of 593 (0%)	0 of 593
Vehicle	0 of 586 (0%)	0 of 586 (0%)	0 of 586

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21681652Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.

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.

Alcon Research, Ltd. study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% in people with Bacterial Conjunctivitis, run by Alcon Research.

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 12 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 2 Jan 2018. 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. Some participants in this study may receive a placebo. 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 22 Mar 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?

Clinical Cure at the Day 4 (EOT)/Exit Visit (time frame: Day 4). 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 NCT00759148, 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 2 Jan 2018.