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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DE-089 ophthalmic solution
DE-089 ophthalmic solution
Placebo 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 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High concentration

Low concentration

Placebo

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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2010
Last Updated
August 8, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01189032
Brief Title
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Official Title
Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II 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
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

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 2
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High concentration
Arm Type
Experimental
Arm Title
Low concentration
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DE-089 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
DE-089 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo 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))

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

Learn more about this trial

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

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