Safety and Efficacy Study of a Eye Drop for Eye Allergy

Vistakon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Placebo; Drug: alcaftadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889330

09-003-05

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Enrollment: 60 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

alcaftadine ophthalmic solution

Experimental group

Description:

active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Treatment:

Drug: alcaftadine

inactive ophthalmic solution vehicle

Placebo Comparator group

Description:

Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Treatment:

Drug: Placebo