Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: AL-4943A ophthalmic solution (Drug); AL-4943A vehicle (Drug); Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Abhijit Narvekar, MS, MBBS, Study Director, Affiliation: Alcon Research
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Ocular Itching at Onset of ActionMean Ocular Itching at 16 Hours Duration of Action
Secondary outcome: Mean Conjunctival Redness at Onset of ActionMean Conjunctival Redness at 16 Hours Duration of Action Mean Total Redness at 24 Hours Duration of Action Mean Ocular Itching at 24 Hours Duration of Action Mean Conjunctival Redness at 24 Hours Duration of Action
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: January 2012
Last updated: May 28, 2013
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