Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

NCT ID: NCT01134328

Last Updated: 2017-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-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-150 Combo

Group Type EXPERIMENTAL

AC-150 Combo

Intervention Type DRUG

1 drop in each eye for up to 14 days

AC-150A 0.1%

Group Type ACTIVE_COMPARATOR

AC-150A 0.1%

Intervention Type DRUG

1 drop in each eye once per day for up to 14 days

AC-150B 0.005%

Group Type ACTIVE_COMPARATOR

AC-150B 0.005%

Intervention Type DRUG

1 drop in each eye once per day for up to 14 days

Vehicle

Group Type OTHER

Vehicle

Intervention Type DRUG

1 drop in each eye once per day for up to 14 days

Interventions

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AC-150 Combo

1 drop in each eye for up to 14 days

Intervention Type DRUG

AC-150A 0.1%

1 drop in each eye once per day for up to 14 days

Intervention Type DRUG

AC-150B 0.005%

1 drop in each eye once per day for up to 14 days

Intervention Type DRUG

Vehicle

1 drop in each eye once per day for up to 14 days

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 or trial parameters.
* Use of disallowed medications during the period indicated prior to study 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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Gail L Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Nicholas P Marsico, MD

Role: PRINCIPAL_INVESTIGATOR

East West Eye Institute

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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10-100-0005

Identifier Type: -

Identifier Source: org_study_id

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