Objective Measurements of Prolonged Effects of Restasis o... | NCT00567177

Studies
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

NCT00567177

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Jul 30, 2010Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Treatment of Dry Eye Disease

Interventions

Restasis, Refresh Plus

Countries

United States

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

Jul 2010

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

Nov 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 2007Estimated

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

Jul 29, 2010

Last Update Posted Date

Jul 30, 2010Estimated

Description Module

Brief Summary

We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Restasis, Refresh Plus
2	Placebo Comparator		Drug: Restasis, Refresh Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restasis, Refresh Plus	Drug	Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening

Measure	Description	Time Frame
Dry Eye disease		6 months

Measure	Description	Time Frame
efficacy		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Using computers more than three hours per day
Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
An abnormal confocal image of 5 or greater.

Exclusion Criteria:

All corneal disorders except for tear disorders.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Yee, MD	Hermann Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hermann Eye Center		6400 Fannin Ste 1800	Texas	77030	United States

Intervention Browse Module

MeSH Terms

ID	Term
D003524	Cyclosporins

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides

Browse Leaves

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Browse Branches

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