Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404131
• Other study ID #: 03-105
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2006
• Last updated: November 28, 2016
• Start date: March 2001
• Est. completion date: December 2001

Study information

• Verified date: November 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• diquafosol tetrasodium (INS365) Ophthalmic Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dry eye testing measures and symptoms
Secondary	Change in dry eye testing measures and symptoms