The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00831662

Purpose

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.

Condition	Intervention	Phase
Dry Eye Disease	Drug: Diquafosol tetrasodium ophthalmic solution, 2% Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders Eye Diseases

Drug Information available for: Diquafosol Ins 365

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	490
Study Start Date:	January 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Arm 2	Drug: Placebo One to two drops in each eye QID for 6 weeks
Experimental: Arm 1	Drug: Diquafosol tetrasodium ophthalmic solution, 2% One to two drops in each eye QID for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831662

Show 47 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Reza Haque, MD, PhD

Medical Monitor, Inspire

More Information

No publications provided

Responsible Party:	Saiid Davari, Inspire
ClinicalTrials.gov Identifier:	NCT00831662 History of Changes
Other Study ID Numbers:	03-113, P08637
Study First Received:	January 27, 2009
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis

Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on February 09, 2012