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Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye

Primary Purpose

Healthy Volunteers, Dry Eye Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-232411
AGN-232411 Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Stage 1

-Healthy participants.

Stage 2 -Participants with the symptoms of dry eye disease.

Exclusion criteria:

Stage 1

-Known allergies or sensitivities to study medications, fluorescein, or lissamine green

Stage 2

  • Known allergies or sensitivities to study medications, fluorescein, or lissamine green
  • Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months
  • History of any ocular surgery within the previous 12 months.

Sites / Locations

  • Sall Research Center
  • Lugene Eye Institute
  • Montebello Medical Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1A: AGN-232411 Dose A

Cohort 1B: AGN-232411 Dose B

Cohort 1C: AGN-232411 Dose C

Cohort 1: AGN-232411 Vehicle

Cohort 2A: AGN-232411 Dose A

Cohort 2B: AGN-232411 Dose B

Cohort 2C: AGN-232411 Dose C

Cohort 2: AGN-232411 Vehicle

Arm Description

One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.

One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable.

One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable.

One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.

One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.

One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable.

One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable.

One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.

Outcomes

Primary Outcome Measures

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
April 15, 2015
Last Updated
July 13, 2016
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02420730
Brief Title
Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1A: AGN-232411 Dose A
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.
Arm Title
Cohort 1B: AGN-232411 Dose B
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable.
Arm Title
Cohort 1C: AGN-232411 Dose C
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable.
Arm Title
Cohort 1: AGN-232411 Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants.
Arm Title
Cohort 2A: AGN-232411 Dose A
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.
Arm Title
Cohort 2B: AGN-232411 Dose B
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable.
Arm Title
Cohort 2C: AGN-232411 Dose C
Arm Type
Experimental
Arm Description
One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable.
Arm Title
Cohort 2: AGN-232411 Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.
Intervention Type
Drug
Intervention Name(s)
AGN-232411
Intervention Description
AGN-232411 topical ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
AGN-232411 Vehicle
Intervention Description
Vehicle for AGN-232411 topical ophthalmic solution.
Primary Outcome Measure Information:
Title
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Stage 1 -Healthy participants. Stage 2 -Participants with the symptoms of dry eye disease. Exclusion criteria: Stage 1 -Known allergies or sensitivities to study medications, fluorescein, or lissamine green Stage 2 Known allergies or sensitivities to study medications, fluorescein, or lissamine green Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months History of any ocular surgery within the previous 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Montebello Medical Center, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye

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