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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:
ClinicalTrials.gov Identifier:
NCT01561521
First Posted: March 23, 2012
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akorn, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]
  • Ocular Redness at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561521


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

Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT01561521     History of Changes
Other Study ID Numbers: 11-100-0008
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: July 18, 2013
Last Verified: May 2012

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