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Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome

This study has been completed.
Sponsor:
Information provided by:
Dhp Korea Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00788229
First received: November 7, 2008
Last updated: April 1, 2010
Last verified: April 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 72
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Study Drugs Drug: AT01
eye drop for 12 weeks
Other Name: DHP-101
Experimental: 2. Study Drug Drug: AT02
eye drop for 12 weeks
Other Name: DHP-300
Experimental: 3. Study Drug Drug: AT03
eye drop for 12 weeks
Other Name: DHP-500
Placebo Comparator: 4. Placebo Drug: AT04
eye drop for 12 weeks
Other Name: Saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Seoul, 388-1 Pungnap-2dong, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Dhp Korea Co., Ltd.
Investigators
Principal Investigator: Hungwon Tchah,, MD Seoul asan medical center
  More Information

No publications provided

Responsible Party: Donghwa Han / The director of Laboratory, Dhp Korea Co., Ltd.
ClinicalTrials.gov Identifier: NCT00788229     History of Changes
Other Study ID Numbers: dhpat02
Study First Received: November 7, 2008
Last Updated: April 1, 2010
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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013