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AGN-229666 for the Treatment of Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
AGN-229666
vehicle of AGN-229666
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AGN-229666 Dose A

AGN-229666 Dose B

vehicle of AGN-229666

Arm Description

One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.

One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.

One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Outcomes

Primary Outcome Measures

Ocular Itching Score at 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.

Secondary Outcome Measures

Ocular Itching Score at 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.
Conjunctival Hyperemia Score
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.

Full Information

First Posted
December 19, 2012
Last Updated
December 17, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01754766
Brief Title
AGN-229666 for the Treatment of Allergic Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-229666 Dose A
Arm Type
Experimental
Arm Description
One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
Arm Title
AGN-229666 Dose B
Arm Type
Experimental
Arm Description
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
Arm Title
vehicle of AGN-229666
Arm Type
Placebo Comparator
Arm Description
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Intervention Type
Drug
Intervention Name(s)
AGN-229666
Intervention Description
One drop of AGN-229666 into each eye on Day 1 and Day 15.
Intervention Type
Other
Intervention Name(s)
vehicle of AGN-229666
Intervention Description
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Primary Outcome Measure Information:
Title
Ocular Itching Score at Day 1
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Ocular Itching Score at Day 15
Description
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.
Time Frame
Day 15
Title
Conjunctival Hyperemia Score
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

AGN-229666 for the Treatment of Allergic Conjunctivitis

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