A Study to Determine the Safety and Tolerability of Escal... | NCT00680108

Studies
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

NCT00680108

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Aug 27, 2015Estimated

Enrollment

62Estimated

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

Sep 1999

Primary Completion Date

May 2000Actual

Completion Date

May 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

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate 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

62Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of adverse events
Ocular symptomatology
Visual acuity
Biomicroscopy
Ophthalmoscopy

Secondary Outcomes

Measure	Description	Time Frame
Unanesthetized Schirmer test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Best corrected visual acuity 20/40 in each eye
2 out 5 specified symptoms
Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion Criteria:

Unable to stop concomitant medications
Have had intraocular surgery in previous 90 days
Have excluded systemic or ocular disease
Wear contact lenses and are not willing to remove them
Have intraocular pressure greater than 22 mg Hg

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