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

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: DA-6034 Placebo; Drug: DA-6034 3%; Drug: DA-6034 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670357

DA6034_DES_II

Details and patient eligibility

About

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

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

DA-6034 Low dose

Experimental group

Description:

DA-6034 3%

Treatment:

Drug: DA-6034 3%

DA-6034 High dose

Experimental group

Description:

DA-6034 5%

Treatment:

Drug: DA-6034 5%

Placebo

Placebo Comparator group

Description:

DA-6034 Placebo

Treatment:

Drug: DA-6034 Placebo