Keratoconjunctival Epithelial DisorderPhase 2NCT01493180
Exploratory Study of OPC-12759 Ophthalmic Suspension
A Phase 2 study testing OPC-12759 ophthalmic suspension and Sodium hyaluronate ophthalmic solution in people with Keratoconjunctival Epithelial Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 10 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Keratoconjunctival Epithelial Disorder
- What is being tested?
- OPC-12759 ophthalmic suspension and Sodium hyaluronate ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesJapan
- Study dates
- Dec 2011to Dec 2012
- 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
- Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
- Fluorescein corneal staining score of 3 or higher
Who cannot join
- Active ocular infection
- Vernal keratoconjunctivitis
- Recurrent corneal erosion
- Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
- Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
- Anticipated use of contact lens during the study.
Show all 9Show fewer
- Insertion of punctal plug or fall out of punctal plug within 3 months
- Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
- Receipt of any investigational product within 4 months.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Kanto region
Hachiōji
Kansai region
Ibaraki
Kansai region
Ikoma
Kansai Region
Kobe
Chugoku region
Kure
Kansai region
Kyoto
Tokai region
Nagoya
Kansai region
Osaka
Kansai region
Sayama
Kanto region
Tokyo
About this study
Official title: Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.
- Conditions
- Keratoconjunctival Epithelial Disorder
- Being tested
- OPC-12759 ophthalmic suspension, Sodium hyaluronate ophthalmic solution
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%
Sodium hyaluronate ophthalmic solutionDrug
Sodium hyaluronate ophthalmic solution 0.1%
| Study group | Role | What they receive |
|---|---|---|
| OPC-12759 ophthalmic suspension | Experimental | OPC-12759 ophthalmic suspension Receives: Drug: OPC-12759 ophthalmic suspension |
| Sodium hyaluronate ophthalmic solution | Active comparator | Sodium hyaluronate ophthalmic solution Receives: Drug: Sodium hyaluronate ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Keratoconjunctival Staining Score From Baseline
Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Measured: Basekine, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionDec 2012
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 Keratoconjunctival Epithelial DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eiji Murakami, Study director, Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493180
- Sponsor's protocol ID
- 037E-11-002
- Other IDs
- JapicCTI-111708
- Status last verified
- Feb 2015
- First submitted
- 13 Dec 2011
- Last updated
- 10 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder
- ClinicalTrials.gov ID
- NCT01493180
- Acronym / sponsor ID
- 037E-11-002
- Conditions
- Keratoconjunctival Epithelial Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Posted 3 Mar 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 efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPC-12759 ophthalmic suspension | Experimental | Drug: OPC-12759 ophthalmic suspensionOPC-12759 ophthalmic suspension |
| Sodium hyaluronate ophthalmic solution | Active comparator | Drug: Sodium hyaluronate ophthalmic solutionSodium hyaluronate ophthalmic solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
- Fluorescein corneal staining score of 3 or higher
Key exclusion criteria (9 listed)
- Active ocular infection
- Vernal keratoconjunctivitis
- Recurrent corneal erosion
- Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
- Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
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 | OPC-12759 ophthalmic suspension |
| Sodium hyaluronate ophthalmic solutionSodium hyaluronate ophthalmic solution 0.1% | Drug | Sodium hyaluronate ophthalmic solution |
Primary outcome
Change in the Keratoconjunctival Staining Score From Baseline
Time frame: Basekine, 4 weeks
Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
10 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 OPC-12759 ophthalmic suspension and Sodium hyaluronate ophthalmic solution in people with Keratoconjunctival Epithelial Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 10 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 2 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 3 Mar 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 the Keratoconjunctival Staining Score From Baseline (time frame: Basekine, 4 weeks). 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 10 Mar 2015.