Dry Eye SyndromesPhase 2NCT00234078
Dose-response Study of OPC-12759 Ophthalmic Suspension
A Phase 2 study testing 0.5% OPC-12759, 1% OPC-12759 and 2% OPC-12759 in people with Dry Eye Syndromes, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic 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?
- 0.5% OPC-12759, 1% OPC-12759 and 2% OPC-12759
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2005to Mar 2007
- 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.
- Primary ocular discomfort severity is moderate to severe.
- Corneal - conjunctival damage is moderate to severe.
- Unanesthetized Schirmer's test score of 7mm/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.
- Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
- Anticipated use of contact lens during the study.
- Any history of ocular surgery within 12 months.
- 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
1 site in 1 country.
About this study
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
- Conditions
- Dry Eye Syndromes
- Being tested
- 0.5% OPC-12759, 1% OPC-12759, 2% OPC-12759, placebo
- Keywords
- OPC-12759, Dry eye syndromes
- 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.
0.5% OPC-12759Drug
1% OPC-12759Drug
2% OPC-12759Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.5% OPC-12759 | Experimental | 0.5% OPC-12759 (rebamipide) ophthalmic suspension Receives: Drug: 0.5% OPC-12759 |
| 1% OPC-12759 | Experimental | 1% OPC-12759 (rebamipide) ophthalmic suspension Receives: Drug: 1% OPC-12759 |
| 2% OPC-12759 | Experimental | 2% OPC-12759 (rebamipide) ophthalmic suspension Receives: Drug: 2% OPC-12759 |
| placebo | Placebo comparator | placebo of OPC-12759 (rebamipide) ophthalmic suspension Receives: Drug: placebo |
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, 12 weeks
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 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, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2006
- Study completionMar 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satoshi Oshima, Study director, Dermatologicals & Ophthalmologicals Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234078
- Sponsor's protocol ID
- 037E-04-002
- Other IDs
- JapicCTI-050040
- Status last verified
- Jan 2014
- First submitted
- 4 Oct 2005
- Last updated
- 28 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Study of OPC-12759 Ophthalmic Suspension
- ClinicalTrials.gov ID
- NCT00234078
- Acronym / sponsor ID
- 037E-04-002
- Conditions
- Dry Eye Syndromes
- Keywords
- OPC-12759, Dry eye syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Posted 28 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 the dose-response of OPC-12759 ophthalmic suspension 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5% OPC-12759 | Experimental | Drug: 0.5% OPC-127590.5% OPC-12759 (rebamipide) ophthalmic suspension |
| 1% OPC-12759 | Experimental | Drug: 1% OPC-127591% OPC-12759 (rebamipide) ophthalmic suspension |
| 2% OPC-12759 | Experimental | Drug: 2% OPC-127592% OPC-12759 (rebamipide) ophthalmic suspension |
| placebo | Placebo comparator | Drug: placeboplacebo of OPC-12759 (rebamipide) 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)
- Outpatient.
- Subjective complaint of dry eye that has been present for minimum 20 months.
- Primary ocular discomfort severity is moderate to severe.
- Corneal - conjunctival damage is moderate to severe.
- Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Key exclusion criteria (7 listed)
- Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
- Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
- Anticipated use of contact lens during the study.
- Any history of ocular surgery within 12 months.
- Female patients who are pregnant, possibly pregnant or breast feeding;
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 |
|---|---|---|
| 0.5% OPC-12759 | Drug | 0.5% OPC-12759 |
| 1% OPC-12759 | Drug | 1% OPC-12759 |
| 2% OPC-12759 | Drug | 2% OPC-12759 |
| placebo | Drug | placebo |
Primary outcome
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time frame: baseline, 12 weeks
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.
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
Time frame: Baseline, 12 weeks
POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
Satoshi Oshima study director
Dermatologicals & Ophthalmologicals Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% OPC-12759, 1% OPC-12759 and 2% OPC-12759 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 6 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 28 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 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. 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 28 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 in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) (time frame: baseline, 12 weeks). 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 28 Feb 2014.