Trial | NCT00386646  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cellulose ...

  • Study Participants

    100
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, 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.
Study Started
Feb 29
2004
Study Completion
Oct 31
2005
Last Update
Jun 03
2015
Estimate

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

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
No Results Posted