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OpenTrials
Completed

NCT Number: NCT02420730

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

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.

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Key information

Conditions

Healthy Volunteers Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sall Research Center, Artesia, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGN-232411

Drug

AGN-232411 topical ophthalmic solution

AGN-232411 Vehicle

Drug

Vehicle for AGN-232411 topical ophthalmic solution.

Primary outcomes

  1. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 56 days

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2015
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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