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 18, 2014
Last verified: July 2014
  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
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Drug: AL-4943A ophthalmic solution vehicle
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
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Ocular Itching at Onset of Action [ Time Frame: Day 14 (3, 5, and 7 minutes post-CAC) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Conjunctival Redness at Onset of Action [ Time Frame: Day 14 (7, 15, and 20 minutes post-CAC) ] [ Designated as safety issue: No ]
    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.

  • Mean Conjunctival Redness at 24 Hours Duration of Action [ Time Frame: Day 1 (7, 15, and 20 minutes post-CAC) ] [ Designated as safety issue: No ]
    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.

  • Mean Total Redness at Onset of Action [ Time Frame: Day 14 (7, 15, and 20 minutes post-CAC) ] [ Designated as safety issue: No ]
    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.

  • Mean Total Redness at 24 Hours Duration of Action [ Time Frame: Day 1 (7, 15, and 20 minutes post-CAC) ] [ Designated as safety issue: No ]
    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.

  • Proportion of Ocular Itching Responders at Onset of Action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Itch Responders at 24 Hours Duration of Action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 902
Study Start Date: January 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 Day 0, followed by 1 drop per eye Day 14
Drug: AL-4943A ophthalmic solution
Active Comparator: PATADAY
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®
Active Comparator: PATANOL
Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Other Name: PATANOL®
Placebo Comparator: Vehicle
AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Drug: AL-4943A ophthalmic solution vehicle

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.

  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 without protocol-specified washout period prior to Visit 1, or during the study.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743027

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abhijit Narvekar, MS, MBBS 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
Results First Received: July 18, 2014
Last Updated: July 18, 2014
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, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014