The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Placebo; Drug: Diquafosol tetrasodium ophthalmic solution, 2%

• Registration Number: NCT00831662
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2011-03-24
• Disposition First Submitted QC: 2011-03-30
• Disposition First Posted: 2011-04-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-21
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Have best corrected visual acuity in both eyes of at least +0.7 or better
• Central corneal staining of 3 on the NEI scale
• If female, are non-pregnant or non-lactating
• Have a history of dry eye disease in both eyes
• Have normal lid anatomy

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Exclusion Criteria

• Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
• Have had ocular surface surgery within the past year
• Are considered legally blind in one eye
• Have a serious medical condition which could confound study assessments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Diquafosol tetrasodium ophthalmic solution, 2%	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)	6 weeks