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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02420730

Enrollment

Registered

2015-04-20

Start date

2015-06-30

Completion date

2016-03-31

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Healthy Volunteers

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.

Interventions

DRUGAGN-232411

AGN-232411 topical ophthalmic solution

DRUGAGN-232411 Vehicle

Vehicle for AGN-232411 topical ophthalmic solution.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to 56 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026