Study of INS365 Ophthalmic Solution in a Controlled Adver... | NCT00037661

Studies
Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

NCT00037661

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 2, 2015Estimated

Enrollment

222Actual

Phase

Phase 3

Conditions

Keratoconjunctivitis Sicca

Interventions

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

Oct 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

Not provided

Start Date

Apr 2002

Primary Completion Date

Mar 2003Actual

Completion Date

Mar 2003Actual

First Submitted Date

May 18, 2002

First Submission Date that Met QC Criteria

May 19, 2002

First Posted Date

May 20, 2002Estimated

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

Oct 1, 2015

Last Update Posted Date

Oct 2, 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

222Actual

Name	Type	Description	Arm Group Labels	Other Names
INS365 Ophthalmic Solution	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months
had intermittent or regular artificial tear use within past 3 months

Exclusion Criteria:

had LASIK surgery
had punctal occlusion or cauterization within last 3 months

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

Condition Browse Module

MeSH Terms

ID	Term
D007638	Keratoconjunctivitis Sicca
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007637	Keratoconjunctivitis
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided