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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386646
• Other study ID #: 152/2004
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: June 2, 2015
• Start date: February 2004
• Est. completion date: October 2005

Study information

• Verified date: October 2006
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 0.5% carboxymethylcellulose (CMC) with purite and CMC alone

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (14)

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

Peter J.McDonnell, John J.Doyle, Lee Stern, and The Dysfunctional Tear Syndrome Group

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.

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. — View Citation

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

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rose Bengal staining
Secondary	Fluorescein staining
Secondary	Total symptoms of dry eye
Secondary	Tear break up time (TBUT)
Secondary	Schirmer I test