- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479374
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
May 28, 2013 updated by: Alcon Research
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
397
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AL-4943A
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
|
Placebo Comparator: Vehicle
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Inactive ingredients used as placebo
|
Active Comparator: Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
|
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.
|
3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Conjunctival Redness at Onset of Action
Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Abhijit Narvekar, MS, MBBS, Alcon Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 24, 2011
Study Record Updates
Last Update Posted (Estimate)
June 4, 2013
Last Update Submitted That Met QC Criteria
May 28, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Olopatadine Hydrochloride
Other Study ID Numbers
- C-10-126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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