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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216096
• Other study ID #: 00891601
• Status: Completed
• Phase: Phase 1
• Start date: September 8, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: August 2018
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal fluorescein staining score	Change in corneal fluorescein staining score at week 4/ at the time of discontinuation	Week 4