Safety and Efficacy Study of a Eye Drop for Eye Allergy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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alcaftadine ophthalmic solution

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

Group Type EXPERIMENTAL

alcaftadine

Intervention Type DRUG

0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

inactive ophthalmic solution vehicle

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle without active, one drop in each eye at each of two visits.

Interventions

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alcaftadine

0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

Intervention Type DRUG

Placebo

Vehicle without active, one drop in each eye at each of two visits.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No