We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240382
First Posted: November 15, 2010
Last Update Posted: August 13, 2014
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
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Condition Intervention Phase
Dry Eye Drug: 3% DE-089 ophthalmic solution Drug: 0.1% sodium hyaluronate ophthalmic solution Phase 3

Study Type: Interventional
Official Title: Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Change in Fluorescein Staining Score From Baseline [ Time Frame: Baseline and 4-week (discontinued (LOCF)) ]

    Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.

    The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.


  • Mean Change in Rose Bengal Staining Score From Baseline [ Time Frame: Baseline and 4-week (discontinued (LOCF)) ]

    Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.

    The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.



Enrollment: 332
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3% DE-089 Drug: 3% DE-089 ophthalmic solution
Active Comparator: 0.1% HA Drug: 0.1% sodium hyaluronate ophthalmic solution

  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:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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): NCT01240382


Locations
Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01240382     History of Changes
Other Study ID Numbers: 00890602
First Submitted: November 12, 2010
First Posted: November 15, 2010
Results First Submitted: May 23, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014

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