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NCT02420730 Clinical Trial

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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02420730
Other study ID # 232411-001
Secondary ID
Status Completed
Phase Phase 1
First received April 15, 2015
Last updated July 13, 2016
Start date June 2015
Est. completion date March 2016

Study information
Verified date July 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Sall Research Center Artesia California
United States Lugene Eye Institute Glendale California
United States Montebello Medical Center, Inc. Montebello California

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) Up to 56 days No
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