A Study of INS365 Ophthalmic Solution in Patients With Mo... | NCT00679718

Studies
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

NCT00679718

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Aug 27, 2015Estimated

Enrollment

150Estimated

Phase

Phase 2

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

Aug 2015

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 2000

Primary Completion Date

Jul 2000Actual

Completion Date

Jul 2000Actual

First Submitted Date

May 15, 2008

First Submission Date that Met QC Criteria

May 16, 2008

First Posted Date

May 19, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2015

Last Update Posted Date

Aug 27, 2015Estimated

Description Module

Brief Summary

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
diquafosol tetrasodium (INS365) ophthalmic solution	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Schirmer scores
Corneal staining
Conjunctival staining
Tear break-up time
Change in artificial tear usage
Patient-reported improvement of foreign body sensation

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity
Investigator global severity assessment
Patient-reported dry eye symptoms other than foreign body sensation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Best corrected visual acuity of at least +0.7 ETDRS
Six month history of dry eye disease
Mild severity in two out of five symptoms
Unanesthetized Schirmer score of less than or equal to 7mm
Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria:

Nasal stimulated Schirmer score of less than 3mm
Have ongoing ocular infection
Have congenitally absent meibomian or lacrimal glands
Have had punctal occlusion within a specified time prior to study
Wear contact lens and refuse to remove them
Have other excluded eye conditions.

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Director	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C403315	diquafosol
D009883	Ophthalmic Solutions

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided