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

Purpose

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.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: 0.5% carboxymethylcellulose (CMC) with purite and CMC alone	Phase 4

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Carboxymethylcellulose sodium Croscarmellose sodium

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Rose Bengal staining

Secondary Outcome Measures:

Fluorescein staining
Total symptoms of dry eye
Tear break up time (TBUT)
Schirmer I test

Estimated Enrollment:	100
Study Start Date:	February 2004
Estimated Study Completion Date:	October 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386646

Locations

Thailand
Chulalongkorn Hospital
Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

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

More Information

Publications:

Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8.

Hikichi T, Yoshida A, Fukui Y, Hamano T, Ri M, Araki K, Horimoto K, Takamura E, Kitagawa K, Oyama M, et al. Prevalence of dry eye in Japanese eye centers. Graefes Arch Clin Exp Ophthalmol. 1995 Sep;233(9):555-8.

Lee AJ, Lee J, Saw SM, Gazzard G, Koh D, Widjaja D, Tan DT. Prevalence and risk factors associated with dry eye symptoms: a population based study in Indonesia. Br J Ophthalmol. 2002 Dec;86(12):1347-51. Review.

Brewitt H, Sistani F. Dry eye disease: the scale of the problem. Surv Ophthalmol. 2001 Mar;45 Suppl 2:S199-202. Review.

Bron AJ. Diagnosis of dry eye. Surv Ophthalmol. 2001 Mar;45 Suppl 2:S221-6. Review.

Sheppard JD. Guidelines for the treatment of chronic dry eye disease. Manag Care. 2003 Dec;12(12 Suppl):20-5. Review.

Horwath-Winter J, Berghold A, Schmut O, Floegel I, Solhdju V, Bodner E, Schwantzer G, Haller-Schober EM. Evaluation of the clinical course of dry eye syndrome. Arch Ophthalmol. 2003 Oct;121(10):1364-8.

Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. Review.

Albietz JM, Lenton LM, McLennan SG, Earl ML. A comparison of the effect of refresh plus and bion tears on dry eye symptoms and ocular surface health in myopic LASIK patients. CLAO J. 2002 Apr;28(2):96-100.

Noecker RJ. Comparison of initial treatment response to two enhanced-viscosity artificial tears. Eye Contact Lens. 2006 May;32(3):148-52.

Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group. Ophthalmology. 2000 Apr;107(4):631-9. Erratum in: Ophthalmology 2000 Jul;107(7):1220.

Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6.

S. Rozen, M. Ableson, A. Giovanoni, et al. Assessment of the comfort and tolerance of 0.5% carboxymethylcellulose preserved with purite (REFRESH TEARSTM) in dry eye sufferers. Invest Ophthalmol Vis Sci. 1998 Mar 15;39(4)S451.

ClinicalTrials.gov Identifier:	NCT00386646 History of Changes
Other Study ID Numbers:	152/2004
Study First Received:	October 10, 2006
Last Updated:	October 10, 2006
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:

Dry eye syndromes therapy

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases

Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013