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

NCT ID: NCT01189032

Last Updated: 2014-08-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye

Study Groups

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High concentration

Group Type EXPERIMENTAL

DE-089 ophthalmic solution

Intervention Type DRUG

Low concentration

Group Type EXPERIMENTAL

DE-089 ophthalmic solution

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

Interventions

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DE-089 ophthalmic solution

Intervention Type DRUG

DE-089 ophthalmic solution

Intervention Type DRUG

Placebo 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

Other Identifiers

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00890404

Identifier Type: -

Identifier Source: org_study_id

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