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

Primary Purpose

Ocular Surface Disease, Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
hydroxypropylmethylcellulose
sodium hyaluronate
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Surface Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Ophthalmology , Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TearA

TearB

Arm Description

Outcomes

Primary Outcome Measures

Ocular surface index score

Secondary Outcome Measures

Eye lid inflammation, corneal staining score, tear break up time and tear volume

Full Information

First Posted
January 25, 2011
Last Updated
January 26, 2011
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01284439
Brief Title
Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma
Official Title
Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Surface Disease, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TearA
Arm Type
Experimental
Arm Title
TearB
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hydroxypropylmethylcellulose
Intervention Description
TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
Intervention Type
Drug
Intervention Name(s)
sodium hyaluronate
Intervention Description
QID to every 2 hous, 1-2 drops per each time, duration 1 month
Primary Outcome Measure Information:
Title
Ocular surface index score
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Eye lid inflammation, corneal staining score, tear break up time and tear volume
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AssocProf Pinnita Tanthuvanit
Phone
02-4198036
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AssocProf Pinnita Tanthuvanit, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology , Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assoc Prof Pinnita Tanthuvanit

12. IPD Sharing Statement

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

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