Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403975
• Other study ID #: 03-109
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2006
• Last updated: February 19, 2016
• Start date: June 2004
• Est. completion date: November 2004

Study information

• Verified date: February 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 assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• 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

• as least mild severity in 1 of the 5 dry eye symptoms

• corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

Exclusion Criteria:

• permanent conjunctival goblet cell loss or scarring conditions

• 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 ophthalmic solution, 2%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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