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AGN-229666 for the Treatment of Allergic Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01754766
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):

December 19, 2012
December 21, 2012
December 17, 2013
February 4, 2014
February 4, 2014
October 2012
January 2013   (Final data collection date for primary outcome measure)
Ocular Itching Score at Day 1 [ Time Frame: Day 1 ]
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.
Ocular Itching Score on a 9-Point Scale [ Time Frame: Day 1 ]
Complete list of historical versions of study NCT01754766 on ClinicalTrials.gov Archive Site
  • Ocular Itching Score at Day 15 [ Time Frame: Day 15 ]
    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 ]
    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.
  • Ocular Itching Score on a 9-Point Scale [ Time Frame: Day 15 ]
  • Conjunctival Hyperemia Score on a 9-Point Scale [ Time Frame: Day 1 ]
Not Provided
Not Provided
 
AGN-229666 for the Treatment of Allergic Conjunctivitis
Not Provided
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: AGN-229666
    One drop 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.
  • Experimental: AGN-229666 Dose A
    One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
    Intervention: Drug: AGN-229666
  • Experimental: AGN-229666 Dose B
    One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
    Intervention: Drug: AGN-229666
  • Placebo Comparator: vehicle of AGN-229666
    One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
    Intervention: Other: vehicle of AGN-229666
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01754766
229666-002
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP