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

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ClinicalTrials.gov Identifier: NCT01240382
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : August 8, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: 3% DE-089 ophthalmic solution Drug: 0.1% sodium hyaluronate ophthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
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 -
Actual Primary Completion Date : February 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: 3% DE-089 Drug: 3% DE-089 ophthalmic solution
Active Comparator: 0.1% HA Drug: 0.1% sodium hyaluronate ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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
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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
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Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT01240382    
Other Study ID Numbers: 00890602
First Posted: November 15, 2010    Key Record Dates
Results First Posted: August 8, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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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