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Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101984
First Posted: April 12, 2010
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santen Pharmaceutical Co., Ltd.
  Purpose
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

Condition Intervention
Dry Eye Drug: diquafosol ophthalmic solution Drug: 0.1% sodium hyaluronate ophthalmic solution.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -

Resource links provided by NLM:


Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Changes in the fluorescein and rose bengal staining score [ Time Frame: 2 weeks and 4 weeks from baseline. ]
    1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
    2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)


Secondary Outcome Measures:
  • Changes in tear film breakup time (second) [ Time Frame: 2 weeks and 4 weeks from baseline. ]
    Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation


Estimated Enrollment: 400
Study Start Date: February 2010
Study Completion Date: April 2012
Arms Assigned Interventions
Experimental: DE-089
DE-089 ophthalmic solution
Drug: diquafosol ophthalmic solution
DE-089 topical ocular application, 6 times daily for 4 weeks.
Other Name: HA
Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.
Active Comparator: HA
0.1% sodium hyaluronate ophthalmic solution
Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Those who show:

    • Keratoconjunctival disorder confirmed with vital dye staining
    • Abnormal Schirmer score results

Exclusion Criteria:

  • Eye disease that needs therapy other than that for dry eye
  • Those who need to wear contact lenses during the clinical study
  Contacts and Locations
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): NCT01101984


Locations
China
Eye & Ear Hospital of Fudan University
Shanghai, China, 200032
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01101984     History of Changes
Other Study ID Numbers: 08901
First Submitted: April 7, 2010
First Posted: April 12, 2010
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents