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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Mahidol University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Mahidol University

ClinicalTrials.gov Identifier:

NCT01284439

First received: January 25, 2011

Last updated: January 26, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

January 26, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular surface index score [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01284439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Eye lid inflammation, corneal staining score, tear break up time and tear volume [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Ocular Surface Disease
Glaucoma

Intervention ^ICMJE

Drug: hydroxypropylmethylcellulose
TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
Drug: sodium hyaluronate
QID to every 2 hous, 1-2 drops per each time, duration 1 month

Study Arm (s)

Experimental: TearA
Intervention: Drug: hydroxypropylmethylcellulose
Experimental: TearB
Intervention: Drug: sodium hyaluronate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

February 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: AssocProf Pinnita Tanthuvanit

02-4198036

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01284439

Other Study ID Numbers ^ICMJE

655/2553(EC4)

Has Data Monitoring Committee

Responsible Party

AssocProf Pinnita Tanthuvanit, Department of Ophthalmology

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

AssocProf Pinnita Tanthuvanit, MD

Mahidol University

Information Provided By

Mahidol University

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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