Status:

COMPLETED

A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

Lead Sponsor:

Alcon Research

Conditions:

Dry Eye

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

Eligibility Criteria

Inclusion

  • Composite corneal staining score of greater than 5 in one or both eyes.
  • Schirmer II score of greater than 4 mm.
  • OSDI score of greater than 23.
  • Other protocol-defined inclusion criteria may apply.

Exclusion

  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
  • Other protocol-defined exclusion criteria may apply.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

765 Patients enrolled

Trial Details

Trial ID

NCT00893139

Start Date

June 1 2009

End Date

January 1 2010

Last Update

July 15 2014

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