Study of the Effect of Diquafosol Tetrasodium Ophthalmic... | NCT00600288

Studies
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

NCT00600288

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jan 9, 2015Estimated

Enrollment

261Actual

Phase

Phase 3

Conditions

Dry Eye Disease

Interventions

diquafosol tetrasodium Ophthalmic Solution, 2%
Non-preserved saline solution (Placebo)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
03-111

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 23, 2008

First Posted Date

Jan 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 24, 2011

Certification/Extension First Submitted that Passed QC Review

Mar 30, 2011

Certification/Extension First Posted Date

Apr 7, 2011Estimated

Last Update Submitted Date

Dec 21, 2014

Last Update Posted Date

Jan 9, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

261Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: diquafosol tetrasodium Ophthalmic Solution, 2%
2	Placebo Comparator		Drug: Non-preserved saline solution (Placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diquafosol tetrasodium Ophthalmic Solution, 2%	Drug	1-2 drops administered in each eye 4 times a day for 6 weeks	1

Measure	Description	Time Frame
Change in fluorescein staining scores of the cornea		6 weeks

Measure	Description	Time Frame
Safety and Tolerability		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent prior to any study procedures being performed.
Have a best corrected visual acuity (BCVAof +0.7 or better.
Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
Have ongoing dry eye disease, in the same qualifying eye or both eyes.

Exclusion Criteria:

Have previously had LASIK refractive surgery.
Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
Have had penetrating intraocular surgery in the past 90 days.
Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
Any serious ocular systemic disease or uncontrolled medical condition.
Exposure to any investigational drug within 30 days of study start.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases