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

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Keelung Chang Gung Memorial Hospital, Keelung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Corneal fluorescein staining score

Time frame: Week 4

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

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 13, 2017
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed