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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akorn, Inc.
ClinicalTrials.gov Identifier:
NCT01561521
First received: March 21, 2012
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: AKF-1
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Akorn, Inc.:

Primary Outcome Measures:
  • Ocular Itching at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
  • Ocular Redness at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AKF-1 0.025% Drug: AKF-1
1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period
Experimental: AKF-1 0.035% Drug: AKF-1
1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period
Placebo Comparator: AKF-1 0% Drug: AKF-1
1 drop 0% in each eye at 2 separate times during a 14 day period

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561521

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Akorn, Inc.
  More Information

No publications provided

Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT01561521     History of Changes
Other Study ID Numbers: 11-100-0008
Study First Received: March 21, 2012
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013