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

Aciex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: AC-150B 0.005%; Drug: Vehicle; Drug: AC-150 Combo; Drug: AC-150A 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134328

10-100-0005

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 4 patient groups

AC-150 Combo

Experimental group

Treatment:

Drug: AC-150 Combo

AC-150A 0.1%

Active Comparator group

Treatment:

Drug: AC-150A 0.1%

AC-150B 0.005%

Active Comparator group

Treatment:

Drug: AC-150B 0.005%

Vehicle

Other group

Treatment:

Drug: Vehicle