Dry Eye SyndromesPhase 3NCT00818324

Long Term Administration Study of OPC-12759 Ophthalmic Suspension

A Phase 3 study testing OPC-12759 Ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites 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 evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: OPC-12759 Ophthalmic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 5 sitesJapan
Study dates: Jan 2009to Jan 2011
Phase: Phase 3
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Out patient;
Ocular discomfort severity is moderate to severe;
Corneal-conjunctival damage is moderate to severe;
Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
Best corrected visual acuity of 0.2 or better in both eyes.

Who cannot join

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
Ocular hypertention patient or glaucoma patient with ophthalmic solution;
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;
Patient with punctal plug;
Any history of ocular surgery within 12 months;

Show all 9Show fewer

Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedual medications;
Receipt of any investigational product within 4 months.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Tohoku Region
Study site
Tokai Region

Other trials in Japan

About this study

Official title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Conditions: Dry Eye Syndromes
Being tested: 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 suspensionDrug
Instillation,4times/day,for 52weeks

Study groups in NCT00818324
Study group	Role	What they receive
OPC-12759 Ophthalmic suspension	Experimental	Instillation, 4times/day Receives: Drug: OPC-12759 Ophthalmic suspension

What is being measured

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

Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Measured: Baseline, Week2, Week4, Week28, Week52

Timeline

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

Jan 2009Jan 2011

First posted7 Jan 2009 (estimated)
Study startJan 2009
Primary completionSep 2010
Study completionJan 2011

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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818324
Sponsor's protocol ID: 037E-08-002
Status last verified: Jan 2014
First submitted: 4 Jan 2009
Last updated: 26 Feb 2014
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 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
ClinicalTrials.gov ID: NCT00818324
Acronym / sponsor ID: 037E-08-002
Conditions: Dry Eye Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Sep 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 7 Jan 2009 (estimated)
Results: Posted 26 Feb 2014

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 evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OPC-12759 Ophthalmic suspension	Experimental	Drug: OPC-12759 Ophthalmic suspensionInstillation, 4times/day

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Out patient;
Ocular discomfort severity is moderate to severe;
Corneal-conjunctival damage is moderate to severe;
Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
Best corrected visual acuity of 0.2 or better in both eyes.

Key exclusion criteria (9 listed)

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
Ocular hypertention patient or glaucoma patient with ophthalmic solution;
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;
Patient with punctal plug;

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 suspensionInstillation,4times/day,for 52weeks	Drug	OPC-12759 Ophthalmic suspension

Primary outcome

Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
Time frame: Baseline, Week2, Week4, Week28, Week52
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).

Results and safety

Results posted to the registry on 26 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% Rebamipide Group	154	127

Primary outcome: Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score

Time frame: Baseline, Week2, Week4, Week28, Week52. Mean (Standard Deviation). Unit: FCS score

Measure	2% Rebamipide Group n = 154
CFB at Week2 (n=154)	-2.2 (2.3)
CFB at Week4 (n=149)	-2.7 (2.4)
CFB at Week28 (n=135)	-4.1 (2.8)
CFB at Week52 (n=127)	-4.6 (2.6)

2% Rebamipide Group: p <0.001, t-test, 2 sided
2% Rebamipide Group: p <0.001, t-test, 2 sided
2% Rebamipide Group: p <0.001, t-test, 2 sided

Adverse events

Time frame: 52 Weeks. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% Rebamipide Group	6 of 154 (3.9%)	125 of 154 (81.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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

OPCJ-DDO

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OPC-12759 Ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites 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 5 inclusion and 9 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 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Feb 2014). 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?

Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score (time frame: Baseline, Week2, Week4, Week28, Week52). 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 NCT00818324.

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 26 Feb 2014.