Pilot Study Evaluation of 2 Artificial Tears. Evaluation... | NCT00469521

Studies
Pilot Study Evaluation of 2 Artificial Tears. Evaluation of TBUT, Tear Meniscus Height and Tear Thickness

NCT00469521

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Sep 10, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Tear Film Thickness

Interventions

Refresh Tears, 9582X

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

Sep 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

May 2, 2007

First Submission Date that Met QC Criteria

May 3, 2007

First Posted Date

May 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

Sep 5, 2007

Last Update Posted Date

Sep 10, 2007Estimated

Description Module

Brief Summary

To determine baseline tear thickness and improvement immediately post installation of two artificial tear solutions:(9582X) and Allergan Refresh Tears.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Refresh Tears, 9582X	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal, healthy volunteers 18 years or older
Males or females
Any race or ethnic background

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study.
Contact lens use on day of examination.
Corneal ectasia

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
Helga Sandoval, MS, MD	Magill Research Center Institute MUSC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magill Research Center Institute MUSC		Charleston	South Carolina	29425	United States