A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)

Aciex Therapeutics

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551056

11-100-0012

Details and patient eligibility

About

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.

Enrollment: 91 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 medication during the period indicated prior to the enrollment or during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups, including a placebo group

AC-170 0.24%

Experimental group

Treatment:

Drug: AC-170 0.24%

AC-170 0%

Placebo Comparator group

Treatment:

Drug: AC-170 0%