Clinical trial NCT01743027: Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Olopatadine HCl solution
Conjunctival Allergen Challenge
Itching eyes
Ocular allergies
PATADAY
PATANOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Mean Ocular Itching at Onset of Action
timeFrame: Day 14 (3, 5, and 7 minutes post-CAC)
measure: Mean Ocular Itching at 24 Hours Duration of Action
timeFrame: Day 1 (3, 5, and 7 minutes post-CAC)
Secondary outcomes:
measure: Mean Conjunctival Redness at Onset of Action
timeFrame: Day 14 (7, 15, and 20 minutes post-CAC)
measure: Mean Conjunctival Redness at 24 Hours Duration of Action
timeFrame: Day 1 (7, 15, and 20 minutes post-CAC)
measure: Mean Total Redness at Onset of Action
timeFrame: Day 14 (7, 15, and 20 minutes post-CAC)
measure: Mean Total Redness at 24 Hours Duration of Action
timeFrame: Day 1 (7, 15, and 20 minutes post-CAC)
measure: Proportion of Ocular Itching Responders at Onset of Action
timeFrame: Day 14
measure: Proportion of Itch Responders at 24 Hours Duration of Action
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Abhijit Narvekar, MS, MBBS
role: STUDY_DIRECTOR
References:
citation: Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.
citation: McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.