NCT02108288

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 2, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

March 27, 2014

Results QC Date

March 23, 2015

Last Update Submit

April 2, 2015

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (2)

  • Cmax of Carteolol

    Day 1 and Day 7

  • Cmax of Latanoprost Acid

    Day 1 and Day 7

Secondary Outcomes (2)

  • Tmax of Carteolol

    Day 1 and Day 7

  • Tmax of Latanoprost Acid

    Day 1 and Day 7

Study Arms (3)

OPC-1085EL ophthalmic solution

EXPERIMENTAL

Once daily

Drug: OPC-1085EL ophthalmic solution

Carteolol long-acting ophthalmic solution

ACTIVE COMPARATOR

Once daily

Drug: Carteolol long-acting ophthalmic solution

Latanoprost ophthalmic solution

ACTIVE COMPARATOR

Once daily

Drug: Latanoprost ophthalmic solution

Interventions

OPC-1085EL ophthalmic solutionDRUG
OPC-1085EL ophthalmic solution
Carteolol long-acting ophthalmic solutionDRUG
Carteolol long-acting ophthalmic solution
Latanoprost ophthalmic solutionDRUG
Latanoprost ophthalmic solution

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subjects with ocular conditions as defined by the protocol
  • Subjects with intraocular pressure: \<10 or ≥22 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kansai Region, Japan

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Director of Clinical Research and Development
Organization
Otsuka Pharmaceutical Co., Ltd
+81-3-6361-7366

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

April 22, 2015

Results First Posted

April 2, 2015

Record last verified: 2015-04

Locations

JP(1)