Study of INS365 Ophthalmic Solution in Subjects With Dry... | NCT00404131

Studies
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT00404131

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Nov 29, 2016Estimated

Enrollment

500Estimated

Phase

Phase 3

Conditions

Dry Eye Disease

Interventions

diquafosol tetrasodium (INS365) Ophthalmic Solution

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

Status Module

Record Verification Date

Nov 2016

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

Mar 2001

Primary Completion Date

Dec 2001Actual

Completion Date

Dec 2001Actual

First Submitted Date

Nov 22, 2006

First Submission Date that Met QC Criteria

Nov 22, 2006

First Posted Date

Nov 27, 2006Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Description Module

Brief 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.

Detailed Description

Not provided

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

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
diquafosol tetrasodium (INS365) Ophthalmic Solution	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in dry eye testing measures and symptoms

Secondary Outcomes

Measure	Description	Time Frame
Change in dry eye testing measures and symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Name	Affiliation	Role
Amy Schaberg, BSN		Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15502479	Result	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. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
C403315	diquafosol
D009883	Ophthalmic Solutions

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses