Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01479374
First received: November 22, 2011
Last updated: June 22, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to assess the safety and efficacy of AL-4943A ophthalmic solution.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Conjunctivitis |
Drug: AL-4943A Ophthalmic Solution Drug: AL-4943A Ophthalmic Solution Vehicle Drug: Pataday |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Ocular Itching [ Time Frame: 3 minutes and 24 hours ] [ Designated as safety issue: No ]Ocular Itching Assessment at Onset and at Duration of Action timepoints
Secondary Outcome Measures:
- Conjunctival redness [ Time Frame: 3 minutes and 24 hours ] [ Designated as safety issue: No ]
- Total redness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]sum of conjunctival, episcleral and ciliary redness
| Enrollment: | 288 |
| Study Start Date: | January 2012 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AL-4943A Ophthalmic Solution
AL-4943A Ophthalmic Solution
|
Drug: AL-4943A Ophthalmic Solution
Ophthalmic Solution being evaluated
|
|
Placebo Comparator: AL-4943A Ophthalmic Solution Vehicle
AL-4943A Ophthalmic Solution Vehicle
|
Drug: AL-4943A Ophthalmic Solution Vehicle
Vehicle for Placebo group
|
|
Active Comparator: Pataday
Pataday
|
Drug: Pataday
Active Comparator for the study
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients, at least 18 years old, of any race or ethnicity.
- Must be able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- Must have a 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.
Exclusion Criteria:
- Known history or presence of persistent dry eye syndrome, or currently requires 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01479374 History of Changes |
| Other Study ID Numbers: | C-10-126 |
| Study First Received: | November 22, 2011 |
| Last Updated: | June 22, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Allergic Conjunctivitis Ocular Allergy |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Olopatadine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013