Keratoconjunctivitis SiccaPhase 2NCT01057147
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
A Phase 2 study testing rebamipide 2% ophthalmic suspension in people with Keratoconjunctivitis Sicca and Dry Eye, run by Kubota Vision Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca, Dry Eye
- What is being tested?
- rebamipide 2% ophthalmic suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis of dry eye as defined by the protocol
- Central corneal staining
Who cannot join
- Ongoing ocular disease that may interfere with study parameters
- Inability to stop using topical ophthalmic medications throughout the duration of the study
- Inability to stop the use of contact lenses for the duration of the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Ora, Inc.
Andover, Massachusetts, 01810
Cohen Laser and Vision Center
Boca Raton, Florida, 33431
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Mundorf Eye Center
Charlotte, North Carolina, 28204
The Cataract & Glaucoma Center
El Paso, Texas, 79902
Nevada Eye Care Professionals
Las Vegas, Nevada, 89119
Avista Eye Center
Las Vegas, Nevada, 89131
Central Maine Eye Care
Lewiston, Maine, 04240
Corneal Consultants of Colorado
Littleton, Colorado, 80120
Macy Eye Center
Los Angeles, California, 90048
George R. John, MD
Louisville, Kentucky, 40205
New York Ophthalmology, PC
Manhasset, New York, 11030
East Valley Ophthalmology
Mesa, Arizona, 85206
Med Eye Associates
Miami, Florida, 33143
Specialty Eye Care
Parker, Colorado, 80134
Arizona Center for Clinical Trials, LLC
Phoenix, Arizona, 85003
Cornea Consultants of Arizona
Phoenix, Arizona, 85032
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye
- Being tested
- rebamipide 2% ophthalmic suspension, placebo eye drops
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebamipide 2% ophthalmic suspensionDrug
Instill one drop in each eye four times daily for 12 weeks.
placebo eye dropsDrug
Instill one drop in each eye four times daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| rebamipide 2% ophthalmic suspension | Experimental | Not described Receives: Drug: rebamipide 2% ophthalmic suspension |
| placebo eye drops | Placebo comparator | Not described Receives: Drug: placebo eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal clearing as measured by fluorescein staining
Measured: 12 weeks
Secondary outcomes (2)
Ocular staining
Measured: 12 weeks
Dry eye symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ryo Kubota, MD, PhD, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057147
- Sponsor's protocol ID
- ACU-RED-204
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2010
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)
- ClinicalTrials.gov ID
- NCT01057147
- Acronym / sponsor ID
- ACU-RED-204
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
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 safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.
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 2% ophthalmic suspension | Experimental | Drug: rebamipide 2% ophthalmic suspension |
| placebo eye drops | Placebo comparator | Drug: placebo eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Diagnosis of dry eye as defined by the protocol
- Central corneal staining
Key exclusion criteria (3 listed)
- Ongoing ocular disease that may interfere with study parameters
- Inability to stop using topical ophthalmic medications throughout the duration of the study
- Inability to stop the use of contact lenses for the duration of the study
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 |
|---|---|---|
| rebamipide 2% ophthalmic suspensionInstill one drop in each eye four times daily for 12 weeks. | Drug | rebamipide 2% ophthalmic suspension |
| placebo eye dropsInstill one drop in each eye four times daily for 12 weeks. | Drug | placebo eye drops |
Primary outcome
Central corneal clearing as measured by fluorescein staining
Time frame: 12 weeks
2 secondary outcomes
Ocular staining
Time frame: 12 weeks
Dry eye symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
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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.
Ryo Kubota, MD, PhD study director
Kubota Vision Inc.
19 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 rebamipide 2% ophthalmic suspension in people with Keratoconjunctivitis Sicca and Dry Eye, run by Kubota Vision Inc. at 19 sites in United States.
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 3 inclusion and 3 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Central corneal clearing as measured by fluorescein staining (time frame: 12 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 11 Jan 2012.