Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386646
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2006-10-10
Brief Title:
Comparative Study of 05 Carboxymethylcellulose With 0005 Stabilized Oxychlorocomplex PURITE Versus 05 Carboxymethylcellulose in the Treatment of Dry Eye
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
A Comparative Study of 05 Carboxymethylcellulose With 0005 Stabilized Oxychlorocomplex PURITE Versus 05 Carboxymethylcellulose in the Treatment of Dry Eye A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare if 05 carboxymethylcellulose with 0005 SOC Stabilized oxychloro complex have the same effectiveness and safety as 05 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 05 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 05 carboxymethylcelluloseCMC with Stabilized OxychlorocomplexSOC and 05 carboxymethylcellulose alone in patients with moderate to severe dry eye symptoms andor signs
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 05 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 05 carboxymethylcelluloseCMC with Stabilized OxychlorocomplexSOC and 05 carboxymethylcellulose alone in patients with moderate to severe dry eye symptoms andor signs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None