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

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ClinicalTrials.gov Identifier: NCT03216096
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 3% DE-089 ophthalmic solution 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



Primary Outcome Measures :
  1. Corneal fluorescein staining score [ Time Frame: Week 4 ]
    Change in corneal fluorescein staining score at week 4/ at the time of discontinuation



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216096


Contacts
Contact: Santen Pharmaceutical Co., Ltd +81-6-4802-9336 clinical@santen.co.jp

Locations
Taiwan
Keelung Chang Gung Memorial Hospital Recruiting
Keelung, Taiwan
Contact       clinical@santen.co.jp   
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact       clinical@santen.co.jp   
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.

Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03216096     History of Changes
Other Study ID Numbers: 00891601
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions