AzTrials
AzTrials

Dry Eye SyndromesPhase 4NCT00386646

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

A Phase 4 study testing 0.5% carboxymethylcellulose (CMC) with purite and CMC alone in people with Dry Eye Syndromes, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
0.5% carboxymethylcellulose (CMC) with purite and CMC alone
How many people
100 participants
Where
1 siteThailand
Study dates
Feb 2004to Oct 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Chulalongkorn Hospital

    Bangkok, Bangkok, 10330

Other trials in Thailand

About this study

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

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.

Read the 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.

Being tested
0.5% carboxymethylcellulose (CMC) with purite and CMC alone
Keywords
Dry eye syndromes therapy
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.5% carboxymethylcellulose (CMC) with purite and CMC aloneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rose Bengal staining

Secondary outcomes (4)

  1. Fluorescein staining

  2. Total symptoms of dry eye

  3. Tear break up time (TBUT)

  4. Schirmer I test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)
  2. Study startFeb 2004
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00386646
Sponsor's protocol ID
152/2004
Status last verified
Oct 2006
First submitted
10 Oct 2006
Last updated
3 Jun 2015
Results posted
No

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

    PubMed 9402817

  • 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.

    PubMed 8543205

  • 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.

    PubMed 12446361

  • 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.

    PubMed 11587143

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

    PubMed 11587146

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

    PubMed 14723110

  • 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.

    PubMed 14557170

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

    PubMed 11783457

  • 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.

    PubMed 12054380

  • 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.

    PubMed 16702870

  • 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.

    PubMed 10768324

  • 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.

    PubMed 15733983

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.5% carboxymethylcellulose (CMC) with purite and CMC alone in people with Dry Eye Syndromes, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rose Bengal staining. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386646, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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