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NCT01284439 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01284439
Other study ID # 655/2553(EC4)
Secondary ID
Status Recruiting
Phase N/A
First received January 25, 2011
Last updated January 26, 2011
Start date January 2011
Est. completion date February 2012

Study information
Verified date January 2011
Source Mahidol University
Contact AssocProf Pinnita Tanthuvanit
Phone 02-4198036
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date February 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand Department of Ophthalmology , Siriraj Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular surface index score 1 month Yes
Secondary Eye lid inflammation, corneal staining score, tear break up time and tear volume 1 month Yes
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