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

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
diquafosol 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 treatment trial for Dry Eye

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Eye & Ear Hospital of Fudan University
  • Singapore Eye Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DE-089

HA

Arm Description

DE-089 ophthalmic solution

0.1% sodium hyaluronate ophthalmic solution

Outcomes

Primary Outcome Measures

Changes in the fluorescein and rose bengal staining score
Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) 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)
Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation

Full Information

First Posted
April 7, 2010
Last Updated
November 11, 2012
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01101984
Brief Title
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DE-089
Arm Type
Experimental
Arm Description
DE-089 ophthalmic solution
Arm Title
HA
Arm Type
Active Comparator
Arm Description
0.1% sodium hyaluronate ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
diquafosol ophthalmic solution
Other Intervention Name(s)
HA
Intervention Description
DE-089 topical ocular application, 6 times daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
0.1% sodium hyaluronate ophthalmic solution.
Intervention Description
0.1% HA topical ocular application, 6 times daily for 4 weeks.
Primary Outcome Measure Information:
Title
Changes in the fluorescein and rose bengal staining score
Description
Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
Time Frame
2 weeks and 4 weeks from baseline.
Secondary Outcome Measure Information:
Title
Changes in tear film breakup time (second)
Description
Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation
Time Frame
2 weeks and 4 weeks from baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Eye & Ear Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
25631485
Citation
Gong L, Sun X, Ma Z, Wang Q, Xu X, Chen X, Shao Y, Yao K, Tang L, Gu Y, Yuan H, Chua WH, Chuan JC, Tong L. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore. Br J Ophthalmol. 2015 Jul;99(7):903-8. doi: 10.1136/bjophthalmol-2014-306084. Epub 2015 Jan 28.
Results Reference
derived

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

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