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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216096

Enrollment

Registered

2017-07-13

Start date

2017-09-08

Completion date

2018-02-01

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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.

Interventions

DRUGPlacebo 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026