Dry Eye SyndromesPhase 3NCT00885079
Confirmatory Study of OPC-12759 Ophthalmic Suspension
A Phase 3 study testing OPC-12759 Ophthalmic suspension and Hyalein Mini Ophthalmic solution in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
Trial summary
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control 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 and Hyalein Mini Ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 5 sitesJapan
- Study dates
- May 2009to Apr 2010
- 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 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
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kyushu region
Kagoshima
Chushikoku region
Matsuyama
Tokai region
Nagoya
Kansai region
Osaka
Kanto region
Tokyo
About this study
Official title: Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
- Conditions
- Dry Eye Syndromes
- Being tested
- OPC-12759 Ophthalmic suspension, Hyalein Mini Ophthalmic solution
- 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
OPC-12759 Ophthalmic suspension 2%
Hyalein Mini Ophthalmic solutionDrug
Hyalein Mini Ophthalmic solution 0.1%
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide | Experimental | Instillation,4 times/day for 4 weeks Receives: Drug: OPC-12759 Ophthalmic suspension |
| Hyaluronate | Active comparator | Instillation,6 times/day for 4 weeks Receives: Drug: Hyalein Mini Ophthalmic solution |
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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Measured: Baseline, Weeks4
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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
Measured: Baseline, Weeks4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionApr 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eiji Murakami, Study chair, OPCJ-DDO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885079
- Sponsor's protocol ID
- 037E-08-001
- Status last verified
- Nov 2013
- First submitted
- 19 Apr 2009
- Last updated
- 12 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT00885079
- Acronym / sponsor ID
- 037E-08-001
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 12 Dec 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 verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebamipide | Experimental | Drug: OPC-12759 Ophthalmic suspensionInstillation,4 times/day for 4 weeks |
| Hyaluronate | Active comparator | Drug: Hyalein Mini Ophthalmic solutionInstillation,6 times/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)
- 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 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 |
|---|---|---|
| OPC-12759 Ophthalmic suspensionOPC-12759 Ophthalmic suspension 2% | Drug | Rebamipide |
| Hyalein Mini Ophthalmic solutionHyalein Mini Ophthalmic solution 0.1% | Drug | Hyaluronate |
Primary outcome
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
Time frame: Baseline, Weeks4
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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
Time frame: Baseline, Weeks4
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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
- 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 and Hyalein Mini Ophthalmic solution 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 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 12 Dec 2013. 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 12 Dec 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 (time frame: Baseline, Weeks4). 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?
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 12 Dec 2013.