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

Dry Eye Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162954
• Other study ID #: DA6034_DES_I
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: September 29, 2014
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• DA-6034

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Clinical Research Institue, Seoul National University Hospital	Seoul, Chongno-Gu, Yon-Gon Dong 28

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular symptomatology, ophthalmologic tests		Single dose: up to 5 days, Multiple dose: up to 15 days
Secondary	Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests		Single dose: up to 10 days, Multiple dose: up to 20 days