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A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

NCT ID: NCT01881113

Last Updated: 2017-11-09

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

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

DOUBLE

Participants Investigators

Study Groups

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AC-170 0.24%

Group Type EXPERIMENTAL

AC-170 0.24%

Intervention Type DRUG

1 drop in each eye at 2 separate times during a 14 day period

AC-170 0%

Group Type PLACEBO_COMPARATOR

AC-170 0%

Intervention Type DRUG

1 drop in each eye at 2 separate times during a 14 day period

Interventions

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AC-170 0.24%

1 drop in each eye at 2 separate times during a 14 day period

Intervention Type DRUG

AC-170 0%

1 drop in each eye at 2 separate times during a 14 day period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aciex Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene McLaurin, MD

Role: PRINCIPAL_INVESTIGATOR

Total Eye Care, PA

Edward Meier, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Care Associates of Greater Cincinnati

Mark Bergmann, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Care Associates of Greater Cincinnati

Locations

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Ora, Inc.

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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13-100-0002

Identifier Type: -

Identifier Source: org_study_id