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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788229
• Other study ID #: dhpat02
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2008
• Last updated: April 1, 2010
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2010
• Source: Dhp Korea Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• AT01
eye drop for 12 weeks
• AT02
eye drop for 12 weeks
• AT03
eye drop for 12 weeks
• AT04
eye drop for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul	388-1 Pungnap-2dong, Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dhp Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break Up Time (TBUT)		12weeks	No
Secondary	Fluorescein staining, schirmer test, OSDI, VAS		12 weeks	Yes