Dry EyePhase 3NCT01660256

Confirmatory Study of OPC-12759 Ophthalmic Solution

A Phase 3 study testing OPC-12759 in people with Dry Eye, run by Otsuka Pharmaceutical Co., Ltd. at 4 sites in Japan.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Dry Eye
What is being tested?: OPC-12759
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 209 participants
Where: 4 sitesJapan
Study dates: Aug 2012to May 2013
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
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 dry eye
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

4 sites in 1 country.

Japan4 sites

Kansai Region
Kansai Region
Kanto region
Kanto Region
Kyushu region
Kyushu Region
Tokai region
Tokai Region

Other trials in Japan

About this study

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

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.

Conditions: Dry Eye
Being tested: OPC-12759, Placebo
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-12759Drug
Also called rebamipide
Instillation, 4 times/day for 4 weeks
PlaceboDrug

Study groups in NCT01660256
Study group	Role	What they receive
OPC-12759 ophthalmic solution	Experimental	OPC-12759 ophthalmic solution Receives: Drug: OPC-12759
Placebo	Placebo comparator	OPC-12759 ophthalmic solution 0% Receives: Drug: Placebo
OPC-12759 ophthalmic suspension	Active comparator	OPC-12759 ophthalmic suspension Receives: Drug: OPC-12759

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
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.
Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.
Measured: Baseline, Week 4

Secondary outcomes (1)

Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better.
The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution.
Measured: Baseline, Week 4

Timeline

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

Aug 2012May 2013

First posted8 Aug 2012 (estimated)
Study startAug 2012
Primary completionMar 2013
Study completionMay 2013

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 EyeStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01660256
Sponsor's protocol ID: 037E-11-003
Other IDs: JapicCTI-121920
Status last verified: Apr 2021
First submitted: 6 Aug 2012
Last updated: 5 May 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 trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye
ClinicalTrials.gov ID: NCT01660256
Acronym / sponsor ID: 037E-11-003
Conditions: Dry Eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Mar 2013 (actual)
Study completion: May 2013 (actual)
First posted: 8 Aug 2012 (estimated)
Results: Posted 5 May 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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
OPC-12759 ophthalmic solution	Experimental	Drug: OPC-12759OPC-12759 ophthalmic solution
Placebo	Placebo comparator	Drug: PlaceboOPC-12759 ophthalmic solution 0%
OPC-12759 ophthalmic suspension	Active comparator	Drug: OPC-12759OPC-12759 ophthalmic suspension

Who may qualify

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

Key inclusion criteria (6 listed)

Out patient
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 dry eye
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
OPC-12759Also: rebamipideInstillation, 4 times/day for 4 weeks	Drug	OPC-12759 ophthalmic solution, OPC-12759 ophthalmic suspension
Placebo	Drug	Placebo

Primary outcome

Change in Fluorescein Corneal Staining (FCS) Score From Baseline
Time frame: Baseline, Week 4
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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.

1 secondary outcome

Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 5 May 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	84	79
Placebo	83	83
OPC-12759 Suspension	42	38

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

Time frame: Baseline, Week 4. Mean (Standard Error). Unit: score on a scale

Measure	OPC-12759 Solution n = 84	Placebo n = 83	OPC-12759 Suspension n = 42
Value	-3.3 (0.2)	-2.0 (0.3)	-2.9 (0.3)

OPC-12759 Solution vs Placebo: Mean Difference (Final Values): -1.3, p <0.001, t-test, 2 sided

Population analysed: Full analysis set consisted of all subjects who had received the investigational product at least once after randomized assignment to a treatment group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment period (4 weeks). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-12759 Solution	0 of 84 (0%)	23 of 84 (27.4%)	0 of 84
Placebo	0 of 83 (0%)	11 of 83 (13.3%)	0 of 83
OPC-12759 Suspension	0 of 42 (0%)	11 of 42 (26.2%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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 director

Director of Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.

4 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 in people with Dry Eye, run by Otsuka Pharmaceutical Co., Ltd. at 4 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 5 May 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?

Change in Fluorescein Corneal Staining (FCS) Score From Baseline (time frame: Baseline, Week 4). 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 NCT01660256.

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 5 May 2021.