Dry Eye SyndromesPhase 2NCT00475319

Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

A Phase 2 study testing 1% OPC-12759 ophthalmic suspension and 2% OPC-12759 ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 6 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 the dose-response of OPC-12759 suspension 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?: 1% OPC-12759 ophthalmic suspension and 2% OPC-12759 ophthalmic suspension
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 308 participants
Where: 6 sitesJapan
Study dates: May 2007to Jun 2008
Phase: Phase 2
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

Outpatient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes 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 sicca
Ocular hypertension 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 procedural medications
Receipt of any investigational product within 4 months

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Study site
Chubu Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region

Other trials in Japan

About this study

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

Conditions: Dry Eye Syndromes
Being tested: placebo, 1% OPC-12759 ophthalmic suspension, 2% OPC-12759 ophthalmic suspension
Keywords: Dry Eye Syndromes, OPC-12759
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.

placeboDrug
comparison of different dosages of drug
1% OPC-12759 ophthalmic suspensionDrug
comparison of different dosages of drug
2% OPC-12759 ophthalmic suspensionDrug
comparison of different dosages of drug

Study groups in NCT00475319
Study group	Role	What they receive
Placebo	Placebo comparator	0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. Receives: Drug: placebo
1% OPC-12759 ophthalmic suspension	Experimental	1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. Receives: Drug: 1% OPC-12759 ophthalmic suspension
2% OPC-12759 ophthalmic suspension	Experimental	2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. Receives: Drug: 2% OPC-12759 ophthalmic suspension

What is being measured

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

Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
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.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.
Measured: Baseline, 4weeks

Secondary outcomes (1)

Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)
LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.
Measured: Baseline, 4weeks

Timeline

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

May 2007Jun 2008

First posted21 May 2007 (estimated)
Study startMay 2007
Primary completionMar 2008
Study completionJun 2008

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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00475319
Sponsor's protocol ID: 037E-06-001
Status last verified: May 2013
First submitted: 16 May 2007
Last updated: 13 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.
PubMed 23009892

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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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
ClinicalTrials.gov ID: NCT00475319
Acronym / sponsor ID: 037E-06-001
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes, OPC-12759
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Mar 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 21 May 2007 (estimated)
Results: Posted 5 Jun 2013

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 the dose-response of OPC-12759 suspension in dry eye patients

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
1% OPC-12759 ophthalmic suspension	Experimental	Drug: 1% OPC-12759 ophthalmic suspension1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
2% OPC-12759 ophthalmic suspension	Experimental	Drug: 2% OPC-12759 ophthalmic suspension2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Outpatient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes or less

Key exclusion criteria (9 listed)

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
Ocular hypertension 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
placebocomparison of different dosages of drug	Drug	Placebo
1% OPC-12759 ophthalmic suspensioncomparison of different dosages of drug	Drug	1% OPC-12759 ophthalmic suspension
2% OPC-12759 ophthalmic suspensioncomparison of different dosages of drug	Drug	2% OPC-12759 ophthalmic suspension

Primary outcome

Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time frame: Baseline, 4weeks
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.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.

1 secondary outcome

Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time frame: Baseline, 4weeks

Results and safety

Results posted to the registry on 5 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1% OPC-12759 Groups	103	101
2% OPC-12759 Groups	102	101
Placebo	103	99

Primary outcome: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)

Time frame: Baseline, 4weeks. Mean (Standard Deviation). Unit: FCS score

Measure	1% OPC-12759 Ophthalmic Suspension n = 103	2% OPC-12759 Ophthalmic Suspension n = 102	Placebo n = 103
Value	-3.5 (2.2)	-3.7 (2.4)	-1.8 (2.0)

1% OPC-12759 Ophthalmic Suspension vs 2% OPC-12759 Ophthalmic Suspension vs Placebo: p = 0.001, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1% OPC-12759 Groups	0 of 103 (0%)	30 of 103 (29.1%)	Not reported
2% OPC-12759 Groups	0 of 102 (0%)	31 of 102 (30.4%)	Not reported
Placebo	1 of 103 (1%)	27 of 103 (26.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23009892Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.

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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.

Satoshi Oshima study director

Division of dermatologicals and ophthalmologicals

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1% OPC-12759 ophthalmic suspension and 2% OPC-12759 ophthalmic suspension in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 6 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 6 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Jun 2013). 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 in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) (time frame: Baseline, 4weeks). 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 NCT00475319, which also lists 1 linked publication.

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 13 Jun 2013.