Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model

Aciex Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: AC-170 0%; Drug: AC-170 0.1%; Drug: AC-170 0.05%; Drug: AC-170 0.24%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332188

11-100-0004

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Enrollment: 101 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 the study enrollment or during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 4 patient groups, including a placebo group

AC-170 0.05%

Experimental group

Treatment:

Drug: AC-170 0.05%

AC-170 0.1%

Experimental group

Treatment:

Drug: AC-170 0.1%

AC-170 0.24%

Experimental group

Treatment:

Drug: AC-170 0.24%

AC-170 0%

Placebo Comparator group

Treatment:

Drug: AC-170 0%