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

This study has been completed.
Sponsor:
Information provided by:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01162954
First received: July 14, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Dry Eye Syndrome
Drug: DA-6034
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

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

Secondary Outcome Measures:
  • 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 ]

Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-6034 Drug: DA-6034
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 14, 2010
Last Updated: August 13, 2013
Health Authority: Korea: Food and Drug Administration

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
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 11, 2014