Cross-Over Evaluation of Two Lubricating Eye Drops | NCT00493662

Studies
Cross-Over Evaluation of Two Lubricating Eye Drops

NCT00493662

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Jan 15, 2008Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Dry Eye

Interventions

Polyethylene Glycol 400 0.4%
Propylene Glycol 0.3%
0.15% sodium Hyaluronate
sodium chloride
sodium phosphate monobasic

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

Jan 2008

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

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 28, 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

Jan 11, 2008

Last Update Posted Date

Jan 15, 2008Estimated

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 yrs or older
Males or females
Any race or ethnic background
Patients with present ocular surface discomfort and a SESoD score of at least 2

Exclusion Criteria:

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

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
Tom Kislan, OD	Hazleton Eye Specialists	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hazleton Eye Specialists		Hazleton	Pennsylvania	18202	United States

ID	Term
D015352	Dry Eye Syndromes

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D006820	Hyaluronic Acid
D012965	Sodium Chloride
C018279	sodium phosphate

Ancestor Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates
D002712	Chlorides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Polyethylene Glycol 400 0.4%	Drug
Propylene Glycol 0.3%	Drug
0.15% sodium Hyaluronate	Drug
sodium chloride	Drug
sodium phosphate monobasic	Drug