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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01561521

Enrollment

Registered

2012-03-23

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Brief summary

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.

Interventions

DRUGAKF-1

1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Ocular Itching at defined time points up to 2 weeks	Baseline to day 14
Ocular Redness at defined time points up to 2 weeks	Baseline to day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026