Allergic ConjunctivitisPhase 4NCT01294969
Patient Perception Study for AL-4943A
A Phase 4 study testing AL-4943A in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in South Korea.
Trial summary
To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- AL-4943A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Oct 2011
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of allergic conjunctivitis within last 24 months
- Active signs and symptoms of ocular allergies
Who cannot join
- Severe or serious ocular condition, ocular surgical intervention, ocular infection
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.
- Conditions
- Allergic Conjunctivitis
- Being tested
- AL-4943A
- Keywords
- Allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-4943ADrug
Once daily topical ocular allergy medication used for 7 days
| Study group | Role | What they receive |
|---|---|---|
| AL-4943A | Experimental | One drop per day in both eyes Receives: Drug: AL-4943A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient satisfaction
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT01294969
- Sponsor's protocol ID
- SMA-10-15
- Status last verified
- Oct 2011
- First submitted
- 10 Feb 2011
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception Study for AL-4943A
- ClinicalTrials.gov ID
- NCT01294969
- Acronym / sponsor ID
- SMA-10-15
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Feb 2011 (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 evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL-4943A | Experimental | Drug: AL-4943AOne drop per day in both eyes |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- History of allergic conjunctivitis within last 24 months
- Active signs and symptoms of ocular allergies
Key exclusion criteria (1 listed)
- Severe or serious ocular condition, ocular surgical intervention, ocular 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-4943AOnce daily topical ocular allergy medication used for 7 days | Drug | AL-4943A |
Primary outcome
Overall Patient satisfaction
Time frame: 7 days
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 16 Dec 2016.
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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 4 study testing AL-4943A in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in South Korea.
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 1 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 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 South Korea. 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?
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?
Overall Patient satisfaction (time frame: 7 days). 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 16 Dec 2016.