Status:

COMPLETED

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Dry Eye Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Eligibility Criteria

Inclusion

  • best corrected visual acuity in both eyes of at least +0.7
  • six-month documented history of dry eye disease
  • at least mild severity in 2 of the 4 dry eye symptoms
  • unanesthetized Schirmer score of less than or equal to 7mm
  • corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion

  • nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
  • ongoing contact lens wear
  • current topical ophthalmic medication use

Key Trial Info

Start Date :

March 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2001

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT00404131

Start Date

March 1 2001

End Date

December 1 2001

Last Update

November 29 2016

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