Clinical trial NCT00386646: Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes therapy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Rose Bengal staining
Secondary outcomes:
measure: Fluorescein staining
measure: Total symptoms of dry eye
measure: Tear break up time (TBUT)
measure: Schirmer I test
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Faculty of Medicine, Chulalongkorn University, Bangkok Thailand
name: Pitipong Suramethakul, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Chulalongkorn University, Bangkok Thailand
name: Vilavun Puangsricharern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Chulalongkorn University, Bangkok Thailand
name: Nipaporn Maneerat, MD
role: STUDY_DIRECTOR
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