A Comparison of Optive in Patients Previously Using Systa... | NCT00399230

Studies
A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye

NCT00399230

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Aug 21, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Dry Eye

Interventions

Optive

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

Aug 2007

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 9, 2006

First Submission Date that Met QC Criteria

Nov 9, 2006

First Posted Date

Nov 14, 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

Aug 17, 2007

Last Update Posted Date

Aug 21, 2007Estimated

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Optive	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

· Dry eye disease diagnosis
- Patients must currently be using Systane tears at least once a day and for at least 1 month.
- Normal lid position and closure
- Male or female of legal age of consent
- Informed consent has been obtained
- Likely to complete all required follow-up visits

Exclusion Criteria:

· Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study.
- Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Accepts Healthy Volunteers

Not provided

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
Rajesh Rajpal, MD	See Clearly Vision Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Rajpal		McLean	Virginia	22102	United States

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases