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

This study has been completed.
Information provided by:
Dhp Korea Co., Ltd. Identifier:
First received: November 7, 2008
Last updated: April 1, 2010
Last verified: April 2010
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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

Primary Outcome Measures:
  • Tear Break Up Time (TBUT) [ Time Frame: 12weeks ]

Secondary Outcome Measures:
  • Fluorescein staining, schirmer test, OSDI, VAS [ Time Frame: 12 weeks ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00788229

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.
Principal Investigator: Hungwon Tchah,, MD Seoul asan medical center
  More Information

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

Keywords provided by Dhp Korea Co., Ltd.:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
artificial tears
carboxymethylcellulose sodium
sodium hyaluronate

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on August 22, 2017