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

NCT ID: NCT01101984

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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DE-089

DE-089 ophthalmic solution

Group Type EXPERIMENTAL

diquafosol ophthalmic solution

Intervention Type DRUG

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

0.1% sodium hyaluronate ophthalmic solution.

Intervention Type DRUG

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

HA

0.1% sodium hyaluronate ophthalmic solution

Group Type ACTIVE_COMPARATOR

0.1% sodium hyaluronate ophthalmic solution.

Intervention Type DRUG

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

Interventions

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diquafosol ophthalmic solution

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

Intervention Type DRUG

0.1% sodium hyaluronate ophthalmic solution.

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

Intervention Type DRUG

Other Intervention Names

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HA

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

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Eye & Ear Hospital of Fudan University

Shanghai, , China

Site Status

Singapore Eye Research Institute

Singapore, Singapore, Singapore

Site Status

Countries

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China Singapore

References

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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.

Reference Type DERIVED
PMID: 25631485 (View on PubMed)

Other Identifiers

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08901

Identifier Type: -

Identifier Source: org_study_id