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Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01162954
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : October 1, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: DA-6034 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)
Study Start Date : September 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DA-6034 Drug: DA-6034
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Ocular symptomatology, ophthalmologic tests [ Time Frame: Single dose: up to 5 days, Multiple dose: up to 15 days ]

Secondary Outcome Measures :
  1. Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests [ Time Frame: Single dose: up to 10 days, Multiple dose: up to 20 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-50 year-old healthy subjects

Exclusion Criteria:

  • Presence or history of dry eye or other ocular or systemic diseases
  • Corrected visual acuity less than 20/40 in either eye at the screening
  • Any eye surgery or laser eye surgery within the past six months
  • Intraocular pressure greater than 22 mmHg in either eye at the screening
  • Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
  • Unanesthetized Schirmer scores <10 mm in either eye at the screening
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162954


Locations
Korea, Republic of
Clinical Research Institue, Seoul National University Hospital
Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D., M.B.A Clinical Research Institute, Seoul National University Hospital
More Information

Responsible Party: Jeong-Seong Hong/Assistant Manager, Clinical Development Team 1
ClinicalTrials.gov Identifier: NCT01162954     History of Changes
Other Study ID Numbers: DA6034_DES_I
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Dong-A ST Co., Ltd.:
Eye drop, Dry eye

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents