Efficacy and Safety of a New Multi-dose Lubricant Eye Dro... | NCT00405457

Studies
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

NCT00405457

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Feb 22, 2010Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Dry Eye

Interventions

Restasis, Optive Tears

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

Feb 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 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Nov 28, 2006

First Submission Date that Met QC Criteria

Nov 28, 2006

First Posted Date

Nov 30, 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

Feb 19, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Description Module

Brief Summary

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other		Drug: Restasis, Optive Tears

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restasis, Optive Tears	Drug	Restasis and Optive Tears use twice daily more frequently if needed	A

Measure	Description	Time Frame
efficacy		1 yr 3 months

Measure	Description	Time Frame
dry eye symptoms		1 yr 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

· Males or females > 18 years old
- Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
- Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

· Patients using Restasis® for less than 3 months.
- Known contraindications to any study medication or ingredients
- Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- Other active uncontrolled ocular diseases or uncontrolled systemic disease

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Hardten, MD	Minnesota Eye Consultants	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minnesota Eye Consultants		Minneapolis	Minnesota	55404	United States

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
D003524	Cyclosporins

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided