NCT03216096

Brief Summary

The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 10, 2017

Last Update Submit

August 30, 2018

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Corneal fluorescein staining score

    Change in corneal fluorescein staining score at week 4/ at the time of discontinuation

    Week 4

Study Arms (1)

3% DE-089 ophthalmic solution

EXPERIMENTAL
Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution

Interventions

Placebo ophthalmic solution and 3% DE-089 ophthalmic solutionDRUG

Placebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period

3% DE-089 ophthalmic solution

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 6-month dry eye history

You may not qualify if:

  • Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
  • Diagnosed with keratoconjunctival chemical burns or thermal burn
  • Eye disease other than dry eye disease which needs treatment
  • Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
  • Those who need to wear contact lenses during the clinical study
  • Those who are considered inappropriate for this study by the investigator or subinvestigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 13, 2017

Study Start

September 8, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

TW(2)