AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Allergan Identifier:
First received: March 6, 2014
Last updated: September 8, 2015
Last verified: September 2015
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.

Condition Intervention Phase
Conjunctivitis, Allergic
Drug: AGN-229666
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale [ Time Frame: Baseline, Day 70 ] [ Designated as safety issue: No ]
    Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Enrollment: 140
Study Start Date: March 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Drug: AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.


Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Japanese patients living in Japan with allergic conjunctivitis with itching and redness
  • Able and willing to discontinue wearing any contact lenses during the study period.

Exclusion Criteria:

  • Eye surgical intervention and/or a history of refractive surgery within 6 months
  • History of retinal detachment, diabetic retinopathy, or progressive retinal disease
  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an eye herpetic infection
  • Use of corticosteroids within 6 months or anticipated use during the study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02082262

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

No publications provided

Responsible Party: Allergan Identifier: NCT02082262     History of Changes
Other Study ID Numbers: 229666-005
Study First Received: March 6, 2014
Results First Received: September 8, 2015
Last Updated: September 8, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on November 30, 2015