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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01743027
First received: December 4, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: AL-4943A ophthalmic solution
Other: AL-4943A ophthalmic solution vehicle
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Ocular itching associated with allergic conjunctivitis at the 24 hours duration of action. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC.

  • Ocular itching associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    A CAC will be performed after drop instillation (Day 14). Ocular itching will be assessed by the patient pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A and AL-4943A Vehicle.


Secondary Outcome Measures:
  • Conjunctival redness associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    A CAC will be performed after drop instillation (Day 14). Conjunctival redness will be assessed by the investigator pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A, PATADAY and AL-4943A Vehicle.

  • Total redness associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    A CAC will be performed after drop instillation (Day 14). Total redness will be assessed by the investigator pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.

  • Conjunctival redness associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Conjunctival redness will be assessed by the investigator post-CAC.

  • Total redness associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Total redness will be assessed by the investigator post-CAC. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.

  • Proportion of ocular itching responders at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC. A responder is defined as a patient 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. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.

  • Proportion of ocular itching responders associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    A CAC will be performed after drop instillation (Day 14). Ocular itching will be assessed by the patient pre-dose and post-CAC. A responder is defined as a patient 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. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.

  • Ocular itching associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC. This outcome measure is pre-specified for PATADAY and AL-4943A Vehicle.


Enrollment: 902
Study Start Date: July 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-4943A
AL-4943A ophthalmic solution, 1 drop per eye, 2 non-consecutive days
Drug: AL-4943A ophthalmic solution
Placebo Comparator: AL-4943A Vehicle
AL-4943A ophthalmic solution vehicle, 1 drop per eye, 2 non-consecutive days
Other: AL-4943A ophthalmic solution vehicle
Active Comparator: PATADAY
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye, 2 non-consecutive days
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®
Active Comparator: PATANOL
Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye, 2 non-consecutive days
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Other Name: PATANOL®

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 occurs. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 during the period indicated prior to Visit 1.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743027

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Undraa Altangerel, MD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01743027     History of Changes
Other Study ID Numbers: C-12-053
Study First Received: December 4, 2012
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Allergic conjunctivitis
Olopatadine HCl solution
Conjunctival Allergen Challenge
Itching eyes
Ocular allergies
PATADAY
PATANOL

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 April 16, 2014