Back to resultsAn Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AKF-1
AKF-1
AKF-1
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AKF-1 0.025%
AKF-1 0.035%
AKF-1 0%
Arm Description
Outcomes
Primary Outcome Measures
Ocular Itching at defined time points up to 2 weeks
Ocular Redness at defined time points up to 2 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561521
Brief Title
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akorn, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AKF-1 0.025%
Arm Type
Experimental
Arm Title
AKF-1 0.035%
Arm Type
Experimental
Arm Title
AKF-1 0%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AKF-1
Intervention Description
1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period
Intervention Type
Drug
Intervention Name(s)
AKF-1
Intervention Description
1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period
Intervention Type
Drug
Intervention Name(s)
AKF-1
Intervention Description
1 drop 0% in each eye at 2 separate times during a 14 day period
Primary Outcome Measure Information:
Title
Ocular Itching at defined time points up to 2 weeks
Time Frame
Baseline to day 14
Title
Ocular Redness at defined time points up to 2 weeks
Time Frame
Baseline to day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
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