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: July 16, 2013
Last verified: May 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 16, 2013
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
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014