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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
  Purpose

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


Condition Intervention
Ocular Surface Disease
Glaucoma
 Drug: hydroxypropylmethylcellulose
Drug: sodium hyaluronate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Mahidol University:

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

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

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AssocProf Pinnita Tanthuvanit, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01284439     History of Changes
Other Study ID Numbers: 655/2553(EC4)
Study First Received: January 25, 2011
Last Updated: January 26, 2011
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on May 23, 2013