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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02420730
Collaborator
(none)
77
3
8
9
25.7
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1A: AGN-232411 Dose A

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Experimental: Cohort 1B: AGN-232411 Dose B

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Experimental: Cohort 1C: AGN-232411 Dose C

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Placebo Comparator: Cohort 1: AGN-232411 Vehicle

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.

Drug: AGN-232411 Vehicle
Vehicle for AGN-232411 topical ophthalmic solution.

Experimental: Cohort 2A: AGN-232411 Dose A

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Experimental: Cohort 2B: AGN-232411 Dose B

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Experimental: Cohort 2C: AGN-232411 Dose C

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.

Drug: AGN-232411
AGN-232411 topical ophthalmic solution

Placebo Comparator: Cohort 2: AGN-232411 Vehicle

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.

Drug: AGN-232411 Vehicle
Vehicle for AGN-232411 topical ophthalmic solution.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [Up to 56 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sall Research Center Artesia California United States 90701
2 Lugene Eye Institute Glendale California United States 91204
3 Montebello Medical Center, Inc. Montebello California United States 90640

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02420730
Other Study ID Numbers:
  • 232411-001
First Posted:
Apr 20, 2015
Last Update Posted:
Jul 14, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2016