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AGN-229666 for the Treatment of Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01754766
First received: December 19, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: AGN-229666
Other: vehicle of AGN-229666
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 Allergan:

Primary Outcome Measures:
  • Ocular Itching Score at Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.


Secondary Outcome Measures:
  • Ocular Itching Score at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

  • Conjunctival Hyperemia Score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.


Enrollment: 90
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-229666 Dose A
One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
Drug: AGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.
Experimental: AGN-229666 Dose B
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
Drug: AGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.
Placebo Comparator: vehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Other: vehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese patients living in Japan with a history of allergic conjunctivitis
  • Willing to discontinue wearing contact lenses during the study period

Exclusion Criteria:

  • Use of nicotine products during the study period
  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an ocular herpetic infection
  • Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
  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: NCT01754766

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01754766     History of Changes
Other Study ID Numbers: 229666-002
Study First Received: December 19, 2012
Results First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on November 23, 2014