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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01162954
• Collaborator: (none)
• Location: 1
• Arms: 2
• Duration (Months): 5.9

Study Details

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
• 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: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

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 [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 [Single dose: up to 10 days, Multiple dose: up to 20 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01162954
• Other Study ID Numbers: DA6034_DES_I
• First Posted: Jul 15, 2010
• Last Update Posted: Oct 1, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by , ,: Eye drop, Dry eye
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Oct 1, 2014