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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2018-02-01

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3% DE-089 ophthalmic solution

Group Type EXPERIMENTAL

Placebo ophthalmic solution and 3% DE-089 ophthalmic solution

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No