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Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

NCT ID: NCT02108288

Last Updated: 2015-04-22

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-08-31

Brief Summary

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OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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OPC-1085EL ophthalmic solution

Once daily

Group Type EXPERIMENTAL

OPC-1085EL ophthalmic solution

Intervention Type DRUG

Carteolol long-acting ophthalmic solution

Once daily

Group Type ACTIVE_COMPARATOR

Carteolol long-acting ophthalmic solution

Intervention Type DRUG

Latanoprost ophthalmic solution

Once daily

Group Type ACTIVE_COMPARATOR

Latanoprost ophthalmic solution

Intervention Type DRUG

Interventions

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OPC-1085EL ophthalmic solution

Intervention Type DRUG

Carteolol long-acting ophthalmic solution

Intervention Type DRUG

Latanoprost ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who are considered medically healthy per investigator's judgment

Exclusion Criteria

* Subjects with ocular conditions as defined by the protocol
* Subjects with intraocular pressure: \<10 or ≥22 mmHg
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kansai Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1085EL-13-004

Identifier Type: -

Identifier Source: org_study_id

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