Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye
To compare if 0.5% carboxymethylcellulose with 0.005% SOC (Stabilized oxychloro complex) have the same effectiveness and safety as 0.5% carboxymethylcellulose on dry eye patients.
Dry Eye Syndromes
Drug: 0.5% carboxymethylcellulose (CMC) with purite and CMC alone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye: A Randomized Controlled Trial|
- Rose Bengal staining
- Fluorescein staining
- Total symptoms of dry eye
- Tear break up time (TBUT)
- Schirmer I test
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||October 2005|
Dry eye is the very common disorder of tear film. There are millions of people who have dry eye around the world. Dry eye patients may suffer from redness, sandy sensation, itching, excessive watering, burning sensation, excessive mucous discharge, blurred vision, contact lens intolerance, and increased risk of ocular surface damage and ocular infection. Currently, there is no curative treatment for dry eye. The mainstay of treatment is still artificial tear supplement or punctual occlusion. In moderate to severe dry eye patients, the standard replacement is using non-preservative artificial tear more than 4 times a day. However, non-preservative artificial tear has some limitation such as inconvenience to carry, expensive, ocular surface trauma due to sharp plastic tip.
Recently, there is improvement in using new disappearing preservatives in artificial tears. One of the new preservative is stabilized Oxychlorocomplex (SOC, Purite™) which can dissipate into water and sodium chloride, components of natural tears when exposed to light. It also has bactericidal and viricidal activities. Scanning electron microscopy also reveals that, carboxymethylcellulose (CMC) with SOC has a very low toxicity to corneal epithelium than other preservative.
The past study had documented that 0.5% CMC preserved with SOC was safe, comfortable and well tolerated for mild to moderate dry eye patients when applying 4-8 times daily.
The objective of this study was comparing efficacy, tolerability, and safety of 0.5% carboxymethylcellulose(CMC) with Stabilized Oxychlorocomplex(SOC) and 0.5% carboxymethylcellulose alone in patients with moderate to severe dry eye symptoms and/or signs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386646
|Bangkok, Thailand, 10330|
|Study Director:||Pitipong Suramethakul, MD||Faculty of Medicine, Chulalongkorn University, Bangkok Thailand|
|Principal Investigator:||Vilavun Puangsricharern, MD||Faculty of Medicine, Chulalongkorn University, Bangkok Thailand|
|Study Director:||Nipaporn Maneerat, MD||Faculty of Medicine, Chulalongkorn University, Bangkok Thailand|