Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome - Full Text View

Sponsored by:	Dhp Korea Co., Ltd.
Information provided by:	Dhp Korea Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00788229

Purpose

The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.

Condition	Intervention	Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca	Drug: AT01 Drug: AT02 Drug: AT03 Drug: AT04	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome

Further study details as provided by Dhp Korea Co., Ltd.:

Primary Outcome Measures:

Tear Break Up Time (TBUT) [ Time Frame: 12weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fluorescein staining, schirmer test, OSDI, VAS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Male and female adults aged 18 years and over.
Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
Subjects must provide signed informed consent prior to participation in any study-related procedures
Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.

Exclusion Criteria:

Pregnancy or lactation.
Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
Any active inflammation of the eye not due to KCS
Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788229

Locations

Korea, Republic of
Asan medical center	Recruiting
seoul, Korea, Republic of, 138-736
Contact: kyunghoon Kim 82 2 3010 5852 hoon0715@lycos.co.kr
Principal Investigator: Hungwon Tchah, MD
Sub-Investigator: Jaeyong Kim, MD

Sponsors and Collaborators

Dhp Korea Co., Ltd.

Investigators

Principal Investigator:

Hungwon Tchah,, MD

Seoul asan medical center

More Information

Responsible Party:	Dhp Korea Co., Ltd. ( Donghwa Han / The director of Laboratory )
Study ID Numbers:	dhpat02
Study First Received:	November 7, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00788229
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Dhp Korea Co., Ltd.:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
artificial tears
carboxymethylcellulose sodium
sodium hyaluronate

Study placed in the following topic categories:

Lacerations
Corneal Diseases
Hyaluronic Acid
Keratoconjunctivitis sicca
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes

Conjunctivitis
Tetrahydrozoline
Keratoconjunctivitis
Conjunctival Diseases
Xerophthalmia
Keratitis
Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009