An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis

Akorn

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: AKF-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561521

11-100-0008

Details and patient eligibility

About

The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.

Enrollment: 90 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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90 participants in 3 patient groups, including a placebo group

AKF-1 0.025%

Experimental group

Treatment:

Drug: AKF-1

Drug: AKF-1

Drug: AKF-1

AKF-1 0.035%

Experimental group

Treatment:

Drug: AKF-1

Drug: AKF-1

Drug: AKF-1

AKF-1 0%

Placebo Comparator group

Treatment:

Drug: AKF-1

Drug: AKF-1

Drug: AKF-1