NCT01101984

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

First QC Date

April 7, 2010

Last Update Submit

November 11, 2012

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Changes in the fluorescein and rose bengal staining score

    1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) 2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)

    2 weeks and 4 weeks from baseline.

Secondary Outcomes (1)

  • Changes in tear film breakup time (second)

    2 weeks and 4 weeks from baseline.

Study Arms (2)

DE-089

EXPERIMENTAL

DE-089 ophthalmic solution

Drug: diquafosol ophthalmic solutionDrug: 0.1% sodium hyaluronate ophthalmic solution.

HA

ACTIVE COMPARATOR

0.1% sodium hyaluronate ophthalmic solution

Drug: 0.1% sodium hyaluronate ophthalmic solution.

Interventions

diquafosol ophthalmic solutionDRUG

DE-089 topical ocular application, 6 times daily for 4 weeks.

Also known as: HA
DE-089
0.1% sodium hyaluronate ophthalmic solution.DRUG

0.1% HA topical ocular application, 6 times daily for 4 weeks.

DE-089HA

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who show:
  • Keratoconjunctival disorder confirmed with vital dye staining
  • Abnormal Schirmer score results

You may not qualify if:

  • Eye disease that needs therapy other than that for dry eye
  • Those who need to wear contact lenses during the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eye & Ear Hospital of Fudan University

Shanghai, 200032, China

Location

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 25631485DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 12, 2010

Study Start

February 1, 2010

Study Completion

April 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

SG(1)CN(1)