Allergic ConjunctivitisPhase 3NCT01743027

Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

A Phase 3 study testing AL-4943A ophthalmic solution, Olopatadine hydrochloride ophthalmic solution, 0.2% and Olopatadine hydrochloride ophthalmic solution, 0.1% in people with Allergic Conjunctivitis, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate an 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, Olopatadine hydrochloride ophthalmic solution, 0.2% and Olopatadine hydrochloride ophthalmic solution, 0.1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 902 participants
Where: No sites listed yet
Study dates: Jan 2013to Jul 2013
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.
Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
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 requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of an ocular condition that may affect the study outcomes.
History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
History of anaphylactic reaction to any allergens used in this study.
Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Phase 3, 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 is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Read the detailed description

Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

Conditions: Allergic Conjunctivitis
Being tested: AL-4943A ophthalmic solution, Olopatadine hydrochloride ophthalmic solution, 0.2%, Olopatadine hydrochloride ophthalmic solution, 0.1%, AL-4943A ophthalmic solution vehicle
Keywords: Allergic conjunctivitis, Olopatadine HCl solution, Conjunctival Allergen Challenge, Itching eyes, Ocular allergies, PATADAY, PATANOL
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
Olopatadine hydrochloride ophthalmic solution, 0.2%Drug
Also called PATADAY®
Olopatadine hydrochloride ophthalmic solution, 0.1%Drug
Also called PATANOL®
AL-4943A ophthalmic solution vehicleDrug

Study groups in NCT01743027
Study group	Role	What they receive
AL-4943A	Experimental	AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 Receives: Drug: AL-4943A ophthalmic solution
PATADAY	Active comparator	Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
PATANOL	Active comparator	Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Vehicle	Placebo comparator	AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 Receives: Drug: AL-4943A ophthalmic solution vehicle

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 installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Measured: Day 14 (3, 5, and 7 minutes post-CAC)
Mean Ocular Itching at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Measured: Day 1 (3, 5, and 7 minutes post-CAC)

Secondary outcomes (6)

Mean Conjunctival Redness at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: Day 14 (7, 15, and 20 minutes post-CAC)
Mean Conjunctival Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: Day 1 (7, 15, and 20 minutes post-CAC)
Mean Total Redness at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
Measured: Day 14 (7, 15, and 20 minutes post-CAC)
Mean Total Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
Measured: Day 1 (7, 15, and 20 minutes post-CAC)
Proportion of Ocular Itching Responders at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
Measured: Day 14
Proportion of Itch Responders at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jul 2013

First posted6 Dec 2012 (estimated)
Study startJan 2013
Primary completionJul 2013
Study completionJul 2013

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 (2)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 902 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01743027
Sponsor's protocol ID: C-12-053
Status last verified: Jul 2014
First submitted: 4 Dec 2012
Last updated: 11 Aug 2014
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
McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.
PubMed 26266427

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
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Daydrop® Triple Action for Allergic Eye Symptoms
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RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, 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: NCT01743027
Acronym / sponsor ID: C-12-053
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis, Olopatadine HCl solution, Conjunctival Allergen Challenge, Itching eyes, Ocular allergies, PATADAY, PATANOL
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 902 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 11 Aug 2014

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 evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
AL-4943A	Experimental	Drug: AL-4943A ophthalmic solutionAL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
PATADAY	Active comparator	Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
PATANOL	Active comparator	Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Vehicle	Placebo comparator	Drug: AL-4943A ophthalmic solution vehicleAL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).

Key exclusion criteria (8 listed)

Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of an ocular condition that may affect the study outcomes.
History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
History of anaphylactic reaction to any allergens used in this study.

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
Olopatadine hydrochloride ophthalmic solution, 0.2%Also: PATADAY®	Drug	PATADAY
Olopatadine hydrochloride ophthalmic solution, 0.1%Also: PATANOL®	Drug	PATANOL
AL-4943A ophthalmic solution vehicle	Drug	Vehicle

Primary outcome

Mean Ocular Itching at Onset of Action
Time frame: Day 14 (3, 5, and 7 minutes post-CAC)
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Mean Ocular Itching at 24 Hours Duration of Action
Time frame: Day 1 (3, 5, and 7 minutes post-CAC)
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

6 secondary outcomes

Mean Conjunctival Redness at Onset of Action
Time frame: Day 14 (7, 15, and 20 minutes post-CAC)
Mean Conjunctival Redness at 24 Hours Duration of Action
Time frame: Day 1 (7, 15, and 20 minutes post-CAC)
Mean Total Redness at Onset of Action
Time frame: Day 14 (7, 15, and 20 minutes post-CAC)
Mean Total Redness at 24 Hours Duration of Action
Time frame: Day 1 (7, 15, and 20 minutes post-CAC)
Proportion of Ocular Itching Responders at Onset of Action
Time frame: Day 14
Proportion of Itch Responders at 24 Hours Duration of Action
Time frame: Day 1

Results and safety

Results posted to the registry on 11 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AL-4943A	98	93
PATADAY	99	94
PATANOL	99	90
Vehicle	49	48

Primary outcome: Mean Ocular Itching at Onset of Action

Time frame: Day 14 (3, 5, and 7 minutes post-CAC). Least squares mean (Standard Error). Unit: units on a scale

Measure	AL-4943A n = 98	PATADAY n = 99	PATANOL n = 99	Vehicle n = 49
3 minutes post-CAC	0.38 (0.069)	0.47 (0.069)	0.59 (0.070)	1.91 (0.095)
5 minutes post-CAC	0.53 (0.075)	0.61 (0.075)	0.79 (0.076)	1.99 (0.103)
7 minutes post-CAC	0.65 (0.081)	0.61 (0.082)	0.83 (0.083)	1.82 (0.113)

Population analysed: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

Primary outcome: Mean Ocular Itching at 24 Hours Duration of Action

Time frame: Day 1 (3, 5, and 7 minutes post-CAC). Least squares mean (Standard Error). Unit: units on a scale

Measure	AL-4943A n = 98	PATADAY n = 99	PATANOL n = 99	Vehicle n = 49
3 minutes post-CAC	1.01 (0.093)	1.33 (0.093)	1.53 (0.093)	2.30 (0.132)
5 minutes post-CAC	1.22 (0.092)	1.48 (0.092)	1.70 (0.091)	2.37 (0.130)
7 minutes post-CAC	1.25 (0.097)	1.41 (0.097)	1.64 (0.096)	2.14 (0.137)

Population analysed: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (6 months). This analysis population includes all participants who were exposed to investigational product for 1-2 instillation(s).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AL-4943A	0 of 98 (0%)	0 of 98 (0%)	Not reported
PATADAY	0 of 99 (0%)	0 of 99 (0%)	Not reported
PATANOL	0 of 99 (0%)	0 of 99 (0%)	Not reported
Vehicle	0 of 49 (0%)	0 of 49 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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.
Derived from this study: PubMed 26266427McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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RecruitingObservational study
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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?

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 8 inclusion and 8 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 11 Aug 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 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 11 Aug 2014). 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: Day 14 (3, 5, and 7 minutes post-CAC)). 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 NCT01743027, which also lists 2 linked publications.

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 11 Aug 2014.