Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01162954
Other study ID # DA6034_DES_I
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02597803 - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 Phase 2/Phase 3
Completed NCT02522312 - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients N/A
Completed NCT01863368 - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining N/A
Completed NCT01753752 - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation Phase 2
Completed NCT01753687 - Correlation of Different Signs for Assessment of Dry Eye Syndrome N/A
Completed NCT01198782 - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% Phase 4
Completed NCT01212471 - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease Phase 3
Completed NCT00535054 - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms N/A
Completed NCT00544713 - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery N/A
Completed NCT00344721 - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome N/A
Completed NCT03830359 - Efficacy, Safety of T2769 in Dry Eye Disease N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Completed NCT02758327 - Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops Phase 4
Completed NCT01970917 - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects Phase 4
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Completed NCT02092207 - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome Phase 2
Completed NCT01541891 - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome Phase 2
Completed NCT01252121 - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline N/A
Completed NCT00765804 - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye Phase 2
Completed NCT00514852 - Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye N/A