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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082262
First Posted: March 10, 2014
Last Update Posted: March 14, 2016
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):
Allergan
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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.

  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:

  • 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
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): NCT02082262


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02082262     History of Changes
Other Study ID Numbers: 229666-005
First Submitted: March 6, 2014
First Posted: March 10, 2014
Results First Submitted: September 8, 2015
Results First Posted: October 8, 2015
Last Update Posted: March 14, 2016
Last Verified: February 2016

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