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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keelung Chang Gung Memorial Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3% DE-089 ophthalmic solution

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2017
Last Updated
August 30, 2018
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03216096
Brief Title
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
Official Title
A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3% DE-089 ophthalmic solution
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Corneal fluorescein staining score
Description
Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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