Assessing Safety and Efficacy of DE-089 Ophthalmic Soluti... | NCT03216096

Studies
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease

NCT03216096

Sponsor

Santen Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Aug 31, 2018Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Dry Eye Disease

Interventions

Placebo ophthalmic solution and 3% DE-089 ophthalmic solution

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2017Actual

Primary Completion Date

Feb 1, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 11, 2017

First Posted Date

Jul 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2018

Last Update Posted Date

Aug 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3% DE-089 ophthalmic solution	Experimental		Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo ophthalmic solution and 3% DE-089 ophthalmic solution	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal fluorescein staining score	Change in corneal fluorescein staining score at week 4/ at the time of discontinuation	Week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 6-month dry eye history

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keelung Chang Gung Memorial Hospital		Keelung			Taiwan
National Taiwan University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided