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

NCT ID: NCT01240382

Last Updated: 2014-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Groups

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3% DE-089

Group Type EXPERIMENTAL

3% DE-089 ophthalmic solution

Intervention Type DRUG

0.1% HA

Group Type ACTIVE_COMPARATOR

0.1% sodium hyaluronate ophthalmic solution

Intervention Type DRUG

Interventions

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3% DE-089 ophthalmic solution

Intervention Type DRUG

0.1% sodium hyaluronate ophthalmic solution

Intervention Type DRUG

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

20 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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Santen study sites

Osaka, Osaka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22914501 (View on PubMed)

Other Identifiers

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00890602

Identifier Type: -

Identifier Source: org_study_id

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