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

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Dry Eye Syndromes

Treatments: Drug: AGN-232411 Vehicle; Drug: AGN-232411

Study type: Interventional

Funder types: Industry

Identifiers

NCT02420730

232411-001

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 8 patient groups, including a placebo group

Cohort 1A: AGN-232411 Dose A

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 1B: AGN-232411 Dose B

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 1C: AGN-232411 Dose C

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 1: AGN-232411 Vehicle

Placebo Comparator group

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.

Treatment:

Drug: AGN-232411 Vehicle

Cohort 2A: AGN-232411 Dose A

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 2B: AGN-232411 Dose B

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 2C: AGN-232411 Dose C

Experimental group

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.

Treatment:

Drug: AGN-232411

Cohort 2: AGN-232411 Vehicle

Placebo Comparator group

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.

Treatment:

Drug: AGN-232411 Vehicle