Allergic ConjunctivitisPhase 3NCT01479374
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
A Phase 3 study testing AL-4943A ophthalmic solution and Olopatadine hydrochloride ophthalmic solution, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model. 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-4943A ophthalmic solution and Olopatadine hydrochloride ophthalmic solution, 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
- History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
- Positive bilateral CAC response at Visit 1 and Visit 2.
- Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
- Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
- Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
- Any contraindications or hypersensitivities to the use of the study medication or their components.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
Read the detailed description
This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.
- Conditions
- Allergic Conjunctivitis
- Being tested
- AL-4943A ophthalmic solution, AL-4943A vehicle, Olopatadine hydrochloride ophthalmic solution, 0.2%
- Keywords
- Allergic Conjunctivitis, Ocular Allergy
- 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-4943A ophthalmic solutionDrug
AL-4943A vehicleDrug
Inactive ingredients used as placebo
Olopatadine hydrochloride ophthalmic solution, 0.2%Drug
Also called PATADAY®
| Study group | Role | What they receive |
|---|---|---|
| AL-4943A | Experimental | AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days Receives: Drug: AL-4943A ophthalmic solution |
| Vehicle | Placebo comparator | AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days Receives: Drug: AL-4943A vehicle |
| Pataday | Active comparator | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ocular Itching at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
Mean Ocular Itching at 16 Hours Duration of Action
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment
Secondary outcomes (5)
Mean Conjunctival Redness at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment
Mean Conjunctival Redness at 16 Hours Duration of Action
A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment
Mean Total Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.
Measured: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
Mean Ocular Itching at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment
Mean Conjunctival Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
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 Allergic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhijit Narvekar, MS, MBBS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479374
- Sponsor's protocol ID
- C-10-126
- Status last verified
- May 2013
- First submitted
- 22 Nov 2011
- Last updated
- 4 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.
PubMed 27466061
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
- ClinicalTrials.gov ID
- NCT01479374
- Acronym / sponsor ID
- C-10-126
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic Conjunctivitis, Ocular Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 23 May 2013
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 was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
Detailed description
This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-4943A | Experimental | Drug: AL-4943A ophthalmic solutionAL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days |
| Vehicle | Placebo comparator | Drug: AL-4943A vehicleAL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days |
| Pataday | Active comparator | Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
- History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
- Positive bilateral CAC response at Visit 1 and Visit 2.
- Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Key exclusion criteria (6 listed)
- Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
- Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
- Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
- Any contraindications or hypersensitivities to the use of the study medication or their components.
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-4943A ophthalmic solution | Drug | AL-4943A |
| AL-4943A vehicleInactive ingredients used as placebo | Drug | Vehicle |
| Olopatadine hydrochloride ophthalmic solution, 0.2%Also: PATADAY® | Drug | Pataday |
Primary outcome
Mean Ocular Itching at Onset of Action
Time frame: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Mean Ocular Itching at 16 Hours Duration of Action
Time frame: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
5 secondary outcomes
Mean Conjunctival Redness at Onset of Action
Time frame: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment
Mean Conjunctival Redness at 16 Hours Duration of Action
Time frame: 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment
Mean Total Redness at 24 Hours Duration of Action
Time frame: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
Mean Ocular Itching at 24 Hours Duration of Action
Time frame: 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment
Mean Conjunctival Redness at 24 Hours Duration of Action
Time frame: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27466061Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.
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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.
Abhijit Narvekar, MS, MBBS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL-4943A ophthalmic solution and Olopatadine hydrochloride ophthalmic solution, 0.2% 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 6 inclusion and 6 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 4 Jun 2013. 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 23 May 2013). 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?
Mean Ocular Itching at Onset of Action (time frame: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment). 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?
On the ClinicalTrials.gov record for NCT01479374, 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 4 Jun 2013.