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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02082262
First received: March 6, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  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: 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 ]

Estimated Enrollment: 125
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
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: NCT02082262

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

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

Additional Information:
No publications provided

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

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 August 25, 2014