Clinical trial NCT00889330: Safety and Efficacy Study of a Eye Drop for Eye Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
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 the efficacy and safety of an anti-allergy eyedrop.


Eligibility criteria: Inclusion Criteria:

* At least 10 years of age
* positive history of ocular allergies
* positive skin test reaction to allergens.

Exclusion Criteria:

* known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
* ocular surgical intervention within three (3) months prior to visit 1 or during the study
* known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
* any other significant illness

Primary outcomes:
measure: Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
timeFrame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
measure: Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
timeFrame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
measure: Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
timeFrame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
measure: Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
timeFrame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
Secondary outcomes:
Other outcomes:
measure: Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
timeFrame: Visit 2 (Day -14) pre-allergen challenge
measure: Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
timeFrame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
measure: Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
timeFrame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
measure: Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
timeFrame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
measure: Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
timeFrame: Visit 2 (Day -14) pre-allergen challenge
measure: Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
timeFrame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
measure: Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
timeFrame: Visit 3 (Day 0) post-dose, pre-allergen challenge
measure: Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
timeFrame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
measure: Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
timeFrame: Visit 4 (Day 14) post-dose, pre-allergen challenge
Locations:
city: Fairfield
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
Study officials:
References:
citation: Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.