Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

— DES  

Official title:

Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670357
• Other study ID #: DA6034_DES_II
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2012
• Last updated: September 29, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

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

Clinical Trial Summary

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Description:

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age=20

2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months

3. Fluorescein corneal staining score = 4 and Schirmer test I = 7mm in same eye

4. Corrected vision = 0.2 in both eye

5. Have given a written, informed consent

Exclusion Criteria:

1. Ocular disorder that may confound interpretation of study results

2. Current treatment for glaucoma or IOP over 25mmHg

3. Ocular surgery history within 1 year

4. Other malignancy history or uncontrolled severe disease within 5 years

5. Use of systemic immunosuppressive therapies within 3 months

6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks

7. Received any other investigational drugs within 4 weeks

8. Subjects who are willing to wear contact lenses during study participation

9. Pregnant or lactating women

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• DA-6034 3%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
• DA-6034 5%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
• DA-6034 Placebo
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's hospital	Seoul

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	Change from baseline of Fluorescein Corneal Staining(FCS) score	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks	No
Secondary	Change from baseline of Tear Break-Up Time(TBUT)	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks	No
Secondary	Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks	No
Secondary	Change from baseline of Schirmer Test I score	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks	No
Secondary	Change from baseline of Ocular Surface Disease Index(OSDI) score	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks	No