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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284439
Recruitment Status : Unknown
Verified January 2011 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : January 27, 2011
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
Mahidol University

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

Condition or disease Intervention/treatment
Ocular Surface Disease Glaucoma Drug: hydroxypropylmethylcellulose Drug: sodium hyaluronate

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TearA Drug: hydroxypropylmethylcellulose
TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
Experimental: TearB Drug: sodium hyaluronate
QID to every 2 hous, 1-2 drops per each time, duration 1 month



Primary Outcome Measures :
  1. Ocular surface index score [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Eye lid inflammation, corneal staining score, tear break up time and tear volume [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284439


Contacts
Contact: AssocProf Pinnita Tanthuvanit 02-4198036

Locations
Thailand
Department of Ophthalmology , Siriraj Hospital Recruiting
Bangkok, Thailand
Principal Investigator: Assoc Prof Pinnita Tanthuvanit         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: AssocProf Pinnita Tanthuvanit, MD Mahidol University

Responsible Party: AssocProf Pinnita Tanthuvanit, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01284439     History of Changes
Other Study ID Numbers: 655/2553(EC4)
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents