Completed

Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

OPC-12759

+ Placebo

+ OPC-12759

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 20 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorOtsuka Pharmaceutical Co., Ltd.
Last updated: May 5, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

NCT01660256
Principal SponsorOtsuka Pharmaceutical Co., Ltd.
Last updated: May 5, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

209 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

6 inclusion criteria required to participate
Best corrected visual acuity of 0.2 or better in both eyes
Corneal - conjunctival damage is moderate to severe
Ocular discomfort severity is moderate to severe
Out patient
Show More Criteria
9 exclusion criteria prevent from participating
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
Anticipated use of contact lens during the study
Any history of ocular surgery within 12 months
Female patients who are pregnant,possibly pregnant or breast feeding
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
OPC-12759 ophthalmic solution

Group II

Placebo
OPC-12759 ophthalmic solution 0%

Group III

Active Comparator
OPC-12759 ophthalmic suspension

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Kansai Region

Kansai Region, JapanOpen Kansai Region in Google Maps

Kanto region

Kanto Region, Japan

Kyushu region

Kyushu Region, Japan

Tokai region

Tokai Region, Japan
Completed4 Study Centers