Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate... | NCT01284439

Studies
Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma

NCT01284439

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Jan 27, 2011Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Ocular Surface Disease
Glaucoma

Interventions

hydroxypropylmethylcellulose
sodium hyaluronate

Countries

Thailand

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Jan 25, 2011

First Submission Date that Met QC Criteria

Jan 26, 2011

First Posted Date

Jan 27, 2011Estimated

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 26, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TearA	Experimental		Drug: hydroxypropylmethylcellulose
TearB	Experimental		Drug: sodium hyaluronate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydroxypropylmethylcellulose	Drug	TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month	TearA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular surface index score		1 month

Secondary Outcomes

Measure	Description	Time Frame
Eye lid inflammation, corneal staining score, tear break up time and tear volume		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

OSDI > or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.

Exclusion Criteria:

Age below 18 yo
Active infectious corneal disease
Post penetrating keratoplasty or glaucoma drainage device
Known allergy to medication
Lactation , Pregnant

Accepts Healthy Volunteers

Yes

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

Name	Role	Phone	Extension	Email
AssocProf Pinnita Tanthuvanit	Contact	02-4198036

Overall Officials

Name	Affiliation	Role
AssocProf Pinnita Tanthuvanit, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology , Siriraj Hospital	Recruiting	Bangkok	Bangkok		Thailand

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065347	Hypromellose Derivatives
D006820	Hyaluronic Acid

Ancestor Terms

ID	Term
D002482	Cellulose
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911

Browse Leaves

Not provided

Browse Branches

Not provided