AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

April 9, 2019 updated by: Allergan
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

  • Presence of active eye infection (bacterial, viral, or fungal)
  • History of an eye herpetic infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGN-229666
One drop of AGN-229666 in each eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.
Placebo Comparator: Vehicle
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
Drug: Vehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
Active Comparator: Olopatadine
One drop of olopatadine in each eye on Days 1 and 15.
Drug: Olopatadine
One drop of olopatadine in the eye on Days 1 and 15.
Other Names:
  • Patanol®
Other: AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.
Drug: Olopatadine
One drop of olopatadine in the eye on Days 1 and 15.
Other Names:
  • Patanol®
Other: AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Drug: AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.
Drug: Vehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Itching Score
Time Frame: Days 1 and 15
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
Days 1 and 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival Hyperemia Score
Time Frame: Days 1 and 15
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.
Days 1 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2014

Primary Completion (Actual)

December 20, 2014

Study Completion (Actual)

December 20, 2014

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229666-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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