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:
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
  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:

  1. Male or female patients, at least 18 years old, of any race or ethnicity.
  2. Must be able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
  3. 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.
  4. History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
  5. Positive bilateral CAC response at Visit 1 and Visit 2.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479374

Locations
United States, Massachusetts
ORA, Inc
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Alcon Research
  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