Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

Last updated: April 9, 2019
Sponsor: Allergan
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eyes

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT01294384
10078X-001
  • Ages > 18
  • All Genders

Study Summary

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current use of an artificial tear product at least twice daily for at least 3 months,on average

  • Ability/agreement to continue wearing existing spectacle correction (glasses) duringstudy

Exclusion

Exclusion Criteria:

  • Anticipated contact lens wear during study or contact lens use within 6 months

  • Active ocular infection or allergy

  • Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucomadrops) within 2 weeks

  • Use of any topical cyclosporine products within 3 months

Study Design

Total Participants: 305
Study Start date:
May 01, 2011
Estimated Completion Date:
September 25, 2012

Connect with a study center

  • Randwick, New South Wales
    Australia

    Site Not Available

  • St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • empty

    St. Johns, Newfoundland and Labrador
    Canada

    Site Not Available

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