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Sponsored by: |
Dhp Korea Co., Ltd. |
---|---|
Information provided by: | Dhp Korea Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00788229 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 72 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1. Study Drugs: Experimental |
Drug: AT01
eye drop for 12 weeks
|
2. Study Drug: Experimental |
Drug: AT02
eye drop for 12 weeks
|
3. Study Drug: Experimental |
Drug: AT03
eye drop for 12 weeks
|
4. Placebo: Placebo Comparator |
Drug: AT04
eye drop for 12 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Asan medical center | Recruiting |
seoul, Korea, Republic of, 138-736 | |
Contact: kyunghoon Kim 82 2 3010 5852 hoon0715@lycos.co.kr | |
Principal Investigator: Hungwon Tchah, MD | |
Sub-Investigator: Jaeyong Kim, MD |
Principal Investigator: | Hungwon Tchah,, MD | Seoul asan medical center |
Responsible Party: | Dhp Korea Co., Ltd. ( Donghwa Han / The director of Laboratory ) |
Study ID Numbers: | dhpat02 |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788229 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Dry Eye Syndromes Keratoconjunctivitis Sicca artificial tears carboxymethylcellulose sodium sodium hyaluronate |
Lacerations Corneal Diseases Hyaluronic Acid Keratoconjunctivitis sicca Eye Diseases Lacrimal Apparatus Diseases Dry Eye Syndromes |
Conjunctivitis Tetrahydrozoline Keratoconjunctivitis Conjunctival Diseases Xerophthalmia Keratitis Keratoconjunctivitis Sicca |
Pathologic Processes Disease Syndrome |