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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, Puriteâ„¢) 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% carboxymethylcellulose (CMC) with purite and CMC alone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rose Bengal staining |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein staining | ||
| Total symptoms of dry eye | ||
| Tear break up time (TBUT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn Hospital | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9402817 | Background | 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. | |
| 8543205 | 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. |
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| Schirmer I test |
| 12446361 | 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. |
| 11587143 | 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. |
| 11587146 | Background | Bron AJ. Diagnosis of dry eye. Surv Ophthalmol. 2001 Mar;45 Suppl 2:S221-6. doi: 10.1016/s0039-6257(00)00201-0. |
| 14723110 | Background | Sheppard JD. Guidelines for the treatment of chronic dry eye disease. Manag Care. 2003 Dec;12(12 Suppl):20-5. |
| 14557170 | 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. |
| 11783457 | Background | Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. doi: 10.1007/BF02853166. |
| 12054380 | 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. |
| 16702870 | 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. |
| 10768324 | 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. |
| 15733983 | 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. |
| 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 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| C035361 | MCC protocol |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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