Dry Eye SyndromesPhase 1NCT01471093

Safety Study of OPC-12759 Ophthalmic Solution

A Phase 1 study testing OPC-12759 Ophthalmic solution and OPC-12759 Ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Syndromes
What is being tested?: OPC-12759 Ophthalmic solution and OPC-12759 Ophthalmic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteJapan
Study dates: Nov 2011to Feb 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Who cannot join

Presence of ocular disorder
Intraocular pressure of 21mmHg or higher
Corrected visual acuity of less than 1.0
Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
History of refractive surgery
History of other ocular surgeries within 12 months
Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose

Trial locations and contacts

1 site in 1 country.

Japan1 site

Kansai region
Osaka

Other trials in Japan

About this study

Official title: Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

Conditions: Dry Eye Syndromes
Being tested: OPC-12759 Ophthalmic solution, OPC-12759 Ophthalmic suspension
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-12759 Ophthalmic solutionDrug
2％ OPC-12759 Ophthalmic solution
OPC-12759 Ophthalmic suspensionDrug
2％ OPC-12759 Ophthalmic suspension

Study groups in NCT01471093
Study group	Role	What they receive
Solution	Experimental	A single dose of OPC-12759 Ophthalmic solution for two-day treatment Receives: Drug: OPC-12759 Ophthalmic solution
Suspension	Active comparator	A single dose of OPC-12759 Ophthalmic suspension for two-day treatment Receives: Drug: OPC-12759 Ophthalmic suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Blurred Vision After Instillation
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Measured: The first and second instillation
Number of Subjects With Bitter Taste
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Measured: The first and second instillation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Feb 2012

First posted11 Nov 2011 (estimated)
Study startNov 2011
Primary completionDec 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01471093
Sponsor's protocol ID: 037E-11-004
Other IDs: JapicCTI-111674
Status last verified: Jun 2021
First submitted: 3 Nov 2011
Last updated: 29 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects
ClinicalTrials.gov ID: NCT01471093
Acronym / sponsor ID: 037E-11-004
Conditions: Dry Eye Syndromes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Dec 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 11 Nov 2011 (estimated)
Results: Posted 29 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Solution	Experimental	Drug: OPC-12759 Ophthalmic solutionA single dose of OPC-12759 Ophthalmic solution for two-day treatment
Suspension	Active comparator	Drug: OPC-12759 Ophthalmic suspensionA single dose of OPC-12759 Ophthalmic suspension for two-day treatment

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Key exclusion criteria (7 listed)

Presence of ocular disorder
Intraocular pressure of 21mmHg or higher
Corrected visual acuity of less than 1.0
Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
History of refractive surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-12759 Ophthalmic solution2％ OPC-12759 Ophthalmic solution	Drug	Solution
OPC-12759 Ophthalmic suspension2％ OPC-12759 Ophthalmic suspension	Drug	Suspension

Primary outcome

Number of Subjects With Blurred Vision After Instillation
Time frame: The first and second instillation
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Number of Subjects With Bitter Taste
Time frame: The first and second instillation
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.

Results and safety

Results posted to the registry on 29 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed	25	24
OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed	25	25
OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed	25	25
OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed	25	25

Primary outcome: Number of Subjects With Blurred Vision After Instillation

Time frame: The first and second instillation. Number. Unit: participants

Measure	OPC-12759 Solution With Nasal Root Pressed/Not Pressed n = 50	OPC-12759 Suspension With Nasal Root Pressed/Not Pressed n = 50
With Nasal Root Press	0	10
Without Nasal Root Press	0	21

Population analysed: Analysis set consisted of all subjects who had received the investigational product at least once.

Primary outcome: Number of Subjects With Bitter Taste

Time frame: The first and second instillation. Number. Unit: participants

Measure	OPC-12759 Solution With Nasal Root Pressed/Not Pressed n = 50	OPC-12759 Suspension With Nasal Root Pressed/Not Pressed n = 50
With Nasal Root Press	33	23
Without Nasal Root Press	41	29

Population analysed: Analysis set consisted of all subjects who had received the investigational product at least once.

Adverse events

Time frame: Treatment period (2 days up to 15 days). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-12759 Solution	0 of 50 (0%)	6 of 50 (12%)	0 of 50
OPC-12759 Suspension	0 of 50 (0%)	2 of 50 (4%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eiji Murakami study chair

Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPC-12759 Ophthalmic solution and OPC-12759 Ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Blurred Vision After Instillation (time frame: The first and second instillation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01471093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.