Bacterial ConjunctivitisPhase 2NCT01238783
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
A Phase 2 study testing AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension, AL-15469A 0.5% and AL-6515 0.3% in people with Bacterial Conjunctivitis, run by Alcon Research.
Trial summary
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension, AL-15469A 0.5% and AL-6515 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 2
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients of any race
- 5 years of age and older at the time of the Day 1 visit
- with a primary clinical diagnosis of bacterial conjunctivitis.
Who cannot join
- Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
- Presence of punctal plug or punctal occlusion
- Visual Acuity worse than 20/80
- Upper respiratory infection
About this study
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis
- Conditions
- Bacterial Conjunctivitis
- Being tested
- AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension, AL-15469A 0.5%, AL-6515 0.3%, Vehicle
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-15469A 0.5% and AL-6515 0.3% Ophthalmic SuspensionDrug
Topical ocular dosed 3 times per day for 3 days
AL-15469A 0.5%Drug
Topical ocular dosed 3 times per day for 3 days
AL-6515 0.3%Drug
Topical ocular dosed 3 times per day for 3 days
VehicleDrug
Topical ocular dosed 3 times per day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension | Experimental | Not described Receives: Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension |
| AL-15469A 0.5% | Experimental | Not described Receives: Drug: AL-15469A 0.5% |
| AL-6515 0.3% | Experimental | Not described Receives: Drug: AL-6515 0.3% |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Clinical Cure rate
Measured: Day 3
End of therapy Clinical Cure rate
Measured: Day 4
Secondary outcomes (2)
Sustained bulbar conjunctival injection
Measured: Day 3
Microbiological Success
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01238783
- Sponsor's protocol ID
- C-09-061
- Status last verified
- Nov 2011
- First submitted
- 9 Nov 2010
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
- ClinicalTrials.gov ID
- NCT01238783
- Acronym / sponsor ID
- C-09-061
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 11 Nov 2010 (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.
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension | Experimental | Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension |
| AL-15469A 0.5% | Experimental | Drug: AL-15469A 0.5% |
| AL-6515 0.3% | Experimental | Drug: AL-6515 0.3% |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients of any race
- 5 years of age and older at the time of the Day 1 visit
- with a primary clinical diagnosis of bacterial conjunctivitis.
Key exclusion criteria (4 listed)
- Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
- Presence of punctal plug or punctal occlusion
- Visual Acuity worse than 20/80
- Upper respiratory infection
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 |
|---|---|---|
| AL-15469A 0.5% and AL-6515 0.3% Ophthalmic SuspensionTopical ocular dosed 3 times per day for 3 days | Drug | AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension |
| AL-15469A 0.5%Topical ocular dosed 3 times per day for 3 days | Drug | AL-15469A 0.5% |
| AL-6515 0.3%Topical ocular dosed 3 times per day for 3 days | Drug | AL-6515 0.3% |
| VehicleTopical ocular dosed 3 times per day for 3 days | Drug | Vehicle |
Primary outcome
Sustained Clinical Cure rate
Time frame: Day 3
End of therapy Clinical Cure rate
Time frame: Day 4
2 secondary outcomes
Sustained bulbar conjunctival injection
Time frame: Day 3
Microbiological Success
Time frame: Day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension, AL-15469A 0.5% and AL-6515 0.3% 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 1 Dec 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Sustained Clinical Cure rate (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2011.