Allergic ConjunctivitisPhase 2NCT01001091
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
A Phase 2 study testing AL-38583 ophthalmic solution and Dexamethasone ophthalmic suspension, 0.1% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- AL-38583 ophthalmic solution and Dexamethasone ophthalmic suspension, 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Apr 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of signs and symptoms of ocular inflammation in both eyes.
- Have a positive CAC response at Visit 1.
- Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Have known history or presence of persistent dry eye syndrome.
- Presence of any ophthalmic abnormality that may affect the study outcomes.
- Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- AL-38583 ophthalmic solution, AL-38583 ophthalmic solution vehicle, Dexamethasone ophthalmic suspension, 0.1%
- Keywords
- Conjunctivitis, conjunctival inflammation, ocular allergies
- Medical subject headings
- Conjunctivitis, Allergic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-38583 ophthalmic solutionDrug
AL-38583 ophthalmic solution vehicleDrug
Inactive ingredients used as a placebo comparator
Dexamethasone ophthalmic suspension, 0.1%Drug
Also called MAXIDEX
| Study group | Role | What they receive |
|---|---|---|
| AL-38583 0.01% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks Receives: Drug: AL-38583 ophthalmic solution |
| AL-38583 0.05% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks Receives: Drug: AL-38583 ophthalmic solution |
| AL-38583 0.2% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks Receives: Drug: AL-38583 ophthalmic solution |
| AL-38583 Vehicle | Placebo comparator | AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks Receives: Drug: AL-38583 ophthalmic solution vehicle |
| MAXIDEX | Active comparator | Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks Receives: Drug: Dexamethasone ophthalmic suspension, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Measured: Day 14
Secondary outcomes (1)
Mean daily diary ocular redness scores
Measured: 2 week period between Day 0 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionApr 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ophthalmic Research Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Michela Palmer, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001091
- Sponsor's protocol ID
- C-09-034
- Status last verified
- Jul 2014
- First submitted
- 22 Oct 2009
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
- ClinicalTrials.gov ID
- NCT01001091
- Acronym / sponsor ID
- C-09-034
- Conditions
- Allergic Conjunctivitis
- Keywords
- Conjunctivitis, conjunctival inflammation, ocular allergies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Ophthalmic Research Associates, Inc.
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Oct 2009 (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 this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AL-38583 0.01% | Experimental | Drug: AL-38583 ophthalmic solutionAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 0.05% | Experimental | Drug: AL-38583 ophthalmic solutionAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 0.2% | Experimental | Drug: AL-38583 ophthalmic solutionAL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 Vehicle | Placebo comparator | Drug: AL-38583 ophthalmic solution vehicleAL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks |
| MAXIDEX | Active comparator | Drug: Dexamethasone ophthalmic suspension, 0.1%Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of signs and symptoms of ocular inflammation in both eyes.
- Have a positive CAC response at Visit 1.
- Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Have known history or presence of persistent dry eye syndrome.
- Presence of any ophthalmic abnormality that may affect the study outcomes.
- Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
- 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 |
|---|---|---|
| AL-38583 ophthalmic solution | Drug | AL-38583 0.01%, AL-38583 0.05%, AL-38583 0.2% |
| AL-38583 ophthalmic solution vehicleInactive ingredients used as a placebo comparator | Drug | AL-38583 Vehicle |
| Dexamethasone ophthalmic suspension, 0.1%Also: MAXIDEX | Drug | MAXIDEX |
Primary outcome
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Time frame: Day 14
1 secondary outcome
Mean daily diary ocular redness scores
Time frame: 2 week period between Day 0 and Day 14
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 17 Jul 2014.
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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.
Michela Palmer study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-38583 ophthalmic solution and Dexamethasone ophthalmic suspension, 0.1% in people with Allergic 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 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: finished, as of the sponsor's last update on 17 Jul 2014. 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 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?
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores (time frame: Day 14). 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 17 Jul 2014.