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

NCT00386646 | Completed Phase 4

• 1 other identifier: 152/2004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromes therapy

Outcome Measures

Primary Outcomes (1)

• Rose Bengal staining

Secondary Outcomes (4)

• Fluorescein staining

• Total symptoms of dry eye

• Tear break up time (TBUT)

• Schirmer I test

Interventions

0.5% carboxymethylcellulose (CMC) with purite and CMC alone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (14)

• 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. doi: 10.1016/s0002-9394(14)71688-5.

  PMID: 9402817 BACKGROUND

• 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. doi: 10.1007/BF00404705.

  PMID: 8543205 BACKGROUND

• 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. doi: 10.1136/bjo.86.12.1347.

  PMID: 12446361 BACKGROUND

• Brewitt H, Sistani F. Dry eye disease: the scale of the problem. Surv Ophthalmol. 2001 Mar;45 Suppl 2:S199-202. doi: 10.1016/s0039-6257(00)00202-2.

  PMID: 11587143 BACKGROUND

• Bron AJ. Diagnosis of dry eye. Surv Ophthalmol. 2001 Mar;45 Suppl 2:S221-6. doi: 10.1016/s0039-6257(00)00201-0.

  PMID: 11587146 BACKGROUND

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

  PMID: 14723110 BACKGROUND

• 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. doi: 10.1001/archopht.121.10.1364.

  PMID: 14557170 BACKGROUND

• Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. doi: 10.1007/BF02853166.

  PMID: 11783457 BACKGROUND

• 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.

  PMID: 12054380 BACKGROUND

• Noecker RJ. Comparison of initial treatment response to two enhanced-viscosity artificial tears. Eye Contact Lens. 2006 May;32(3):148-52. doi: 10.1097/01.icl.0000181819.63425.a6.

  PMID: 16702870 BACKGROUND

• 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. doi: 10.1016/s0161-6420(99)00176-1.

  PMID: 10768324 BACKGROUND

• 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. doi: 10.1016/j.ajo.2004.08.040.

  PMID: 15733983 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium; MCC protocol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Pitipong Suramethakul, MD

  Faculty of Medicine, Chulalongkorn University, Bangkok Thailand

  STUDY DIRECTOR

• Vilavun Puangsricharern, MD

  Faculty of Medicine, Chulalongkorn University, Bangkok Thailand

  PRINCIPAL INVESTIGATOR

• Nipaporn Maneerat, MD

  Faculty of Medicine, Chulalongkorn University, Bangkok Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: February 1, 2004
• Study Completion: October 1, 2005
• Last Updated: June 3, 2015

Record last verified: 2006-10

Locations

TH (1)