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Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386646
First Posted: October 11, 2006
Last Update Posted: June 3, 2015
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.
Information provided by:
Chulalongkorn University
October 10, 2006
October 11, 2006
June 3, 2015
February 2004
Not Provided
Rose Bengal staining
Same as current
Complete list of historical versions of study NCT00386646 on ClinicalTrials.gov Archive Site
  • Fluorescein staining
  • Total symptoms of dry eye
  • Tear break up time (TBUT)
  • Schirmer I test
Same as current
Not Provided
Not Provided
 
Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye
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
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 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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Dry Eye Syndromes
Drug: 0.5% carboxymethylcellulose (CMC) with purite and CMC alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2005
Not Provided

Inclusion Criteria:

  • Out patients of Ophthalmology department, King Chulalongkorn Memorial Hospital, who have symptoms and/or signs of dry eye
  • Bilateral dry eye symptoms and/or signs with equal severity between both eyes
  • Age > 18 years, capable of following the study protocol, and considered be able to return for all scheduled visit

Exclusion Criteria:

  • Different severity of dryness between both eyes
  • Current or recent use of topical ophthalmic medications that could affect dry eye condition
  • History of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of study result
  • Recent contact lens wear (within one month)
  • Known hypersensitivity to 0.005% SOC or carboxymethylcellulose
  • Pregnancy or planned pregnancy
  • Having received permanent punctal occlusion
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00386646
152/2004
Not Provided
Not Provided
Not Provided
Not Provided
Chulalongkorn University
Not Provided
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
Chulalongkorn University
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP