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
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 |
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan medical center | Seoul | 388-1 Pungnap-2dong, Songpa-gu |
Lead Sponsor | Collaborator |
---|---|
Dhp Korea Co., Ltd. |
Korea, Republic of,
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 |
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