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Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

NCT02815293 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-19

Study results available
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Summary

The objectives of this study are twofold

* To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE)
* To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

AGN-195263

1 drop of AGN-195263 will be instilled in each eye twice daily.

DRUG

Vehicle

1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815293 on ClinicalTrials.gov