AGN-229666 for the Treatment of Allergic Conjunctivitis

December 17, 2013 updated by: Allergan
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

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
  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGN-229666 Dose A
One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
Drug: AGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.
Experimental: AGN-229666 Dose B
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
Drug: AGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.
Placebo Comparator: vehicle of AGN-229666
One drop of vehicle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 15
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.
Day 1

Collaborators and Investigators

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

Sponsor

Allergan

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

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229666-002

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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