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

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AT01
AT02
AT03
AT04
Sponsored by
Dhp Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1. Study Drugs

2. Study Drug

3. Study Drug

4. Placebo

Arm Description

Outcomes

Primary Outcome Measures

Tear Break Up Time (TBUT)

Secondary Outcome Measures

Fluorescein staining, schirmer test, OSDI, VAS

Full Information

First Posted
November 7, 2008
Last Updated
April 1, 2010
Sponsor
Dhp Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00788229
Brief Title
Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dhp Korea Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Keywords
Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Study Drugs
Arm Type
Experimental
Arm Title
2. Study Drug
Arm Type
Experimental
Arm Title
3. Study Drug
Arm Type
Experimental
Arm Title
4. Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AT01
Other Intervention Name(s)
DHP-101
Intervention Description
eye drop for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AT02
Other Intervention Name(s)
DHP-300
Intervention Description
eye drop for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AT03
Other Intervention Name(s)
DHP-500
Intervention Description
eye drop for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AT04
Other Intervention Name(s)
Saline
Intervention Description
eye drop for 12 weeks
Primary Outcome Measure Information:
Title
Tear Break Up Time (TBUT)
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
Fluorescein staining, schirmer test, OSDI, VAS
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hungwon Tchah,, MD
Organizational Affiliation
Seoul asan medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
State/Province
388-1 Pungnap-2dong, Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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

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