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: May 28, 2013
Last verified: May 2013

November 22, 2011
May 28, 2013
January 2012
March 2012   (final data collection date for primary outcome measure)
  • Mean Ocular Itching at Onset of Action [ Time Frame: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
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
Complete list of historical versions of study NCT01479374 on ClinicalTrials.gov Archive Site
  • Mean Conjunctival Redness at Onset of Action [ Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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
Not Provided
Not Provided
 
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: AL-4943A ophthalmic solution
  • Drug: AL-4943A vehicle
    Inactive ingredients used as placebo
  • Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
    Other Name: PATADAY®
  • Experimental: AL-4943A
    AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
    Intervention: Drug: AL-4943A ophthalmic solution
  • Placebo Comparator: Vehicle
    AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
    Intervention: Drug: AL-4943A vehicle
  • Active Comparator: Pataday
    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
    Intervention: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
397
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01479374
C-10-126
No
Alcon Research
Alcon Research
Not Provided
Study Director: Abhijit Narvekar, MS, MBBS Alcon Research
Alcon Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP