Bacterial ConjunctivitisPhase 3NCT00332293
AL-15469A for the Treatment of Bacterial Conjunctivitis
A Phase 3 study testing Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% and Moxifloxacin hydrochloride ophthalmic solution 0.5% as base in people with Bacterial Conjunctivitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis. 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 Ophthalmic Solution 0.5% and Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2006
- Phase
- Phase 3
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- signs and symptoms of bacterial conjunctivitis
- Other protocol-defined inclusion criteria may apply
Who cannot join
- under 1 mo. age
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%, Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%Drug
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
Moxifloxacin hydrochloride ophthalmic solution 0.5% as baseDrug
Also called VIGAMOX
1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Not described Receives: Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% |
| VIGAMOX | Active comparator | Not described Receives: Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure and microbiological success
Secondary outcomes (1)
Individual signs and symptoms of bacterial conjunctivitis at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332293
- Sponsor's protocol ID
- C-04-40
- Status last verified
- Mar 2012
- First submitted
- 31 May 2006
- Last updated
- 18 Nov 2016
- Results posted
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
- ClinicalTrials.gov ID
- NCT00332293
- Acronym / sponsor ID
- C-04-40
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Jun 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 the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% |
| VIGAMOX | Active comparator | Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- signs and symptoms of bacterial conjunctivitis
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (2 listed)
- under 1 mo. age
- Other protocol-defined exclusion criteria may apply
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 Ophthalmic Solution 0.5%1 drop into the conjunctival sac of both eyes 3 times a day for 3 days | Drug | Moxifloxacin |
| Moxifloxacin hydrochloride ophthalmic solution 0.5% as baseAlso: VIGAMOX1 drop into the conjunctival sac of both eyes 3 times a day for 3 days | Drug | VIGAMOX |
Primary outcome
Clinical cure and microbiological success
1 secondary outcome
Individual signs and symptoms of bacterial conjunctivitis at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% and Moxifloxacin hydrochloride ophthalmic solution 0.5% as base in people with Bacterial Conjunctivitis, run by Alcon Research 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 2 inclusion and 2 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 18 Nov 2016. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and microbiological success. 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 NCT00332293, 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 18 Nov 2016.