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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
3% DE-089 ophthalmic solution
0.1% sodium hyaluronate ophthalmic solution
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Dry Eye

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Santen study sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3% DE-089

0.1% HA

Arm Description

Outcomes

Primary Outcome Measures

Mean Change in Fluorescein Staining Score From Baseline
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2010
Last Updated
August 8, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01240382
Brief Title
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Study Phase
Phase 3
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3% DE-089
Arm Type
Experimental
Arm Title
0.1% HA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
3% DE-089 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
0.1% sodium hyaluronate ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Change in Fluorescein Staining Score From Baseline
Description
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.
Time Frame
Baseline and 4-week (discontinued (LOCF))
Title
Mean Change in Rose Bengal Staining Score From Baseline
Description
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.
Time Frame
Baseline and 4-week (discontinued (LOCF))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility 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
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22914501
Citation
Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.
Results Reference
derived

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

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