Dry Eye SyndromePhase 3NCT01632137
Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
A Phase 3 study testing Rebamipide 2% ophthalmic suspension in people with Dry Eye Syndrome, run by Kubota Vision Inc. at 34 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Rebamipide 2% ophthalmic suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- 34 sitesUnited States
- Study dates
- Jun 2012to Jun 2013
- Phase
- Phase 3
- 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
- History of dry eye-related ocular symptoms for at least 20 months.
- Meet protocol-defined criteria for corneal and conjunctival staining.
- Meet protocol-defined criteria for ocular discomfort.
Who cannot join
- Active anterior segment ocular disease other than dry eye syndrome.
- Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
- Inability to suspend the use of contact lenses for the duration of the study.
- Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
- Received any other investigational product within 4 months before the screening visit.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Artesia, California
Study site
Ashville, North Carolina
Study site
Baton Rouge, Louisiana
Study site
Charlotte, North Carolina
Study site
Chattanooga, Tennessee
Study site
Cleveland, Ohio
Study site
Fort Myers, Florida
Study site
Glendale, California
Study site
Houston, Texas
Study site
Inglewood, California
Study site
Kansas City, Missouri
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Lutherville, Maryland
Study site
Mason, Ohio
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Morrow, Georgia
Study site
Norfolk, Virginia
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Plantation, Florida
Study site
Princeton, New Jersey
Study site
Rochester, New York
Study site
Rockville Centre, New York
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
St Louis, Missouri
Study site
Stuart, Florida
Study site
Tampa, Florida
Study site
Valley Stream, New York
Study site
Wantagh, New York
Study site
Washington, Missouri
Study site
Wheat Ridge, Colorado
About this study
Official title: A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
- Conditions
- Dry Eye Syndrome
- Being tested
- Rebamipide 2% ophthalmic suspension, Placebo (vehicle)
- 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.
Rebamipide 2% ophthalmic suspensionDrug
Instill one drop into each eye 4 times a day for 4 weeks.
Placebo (vehicle)Drug
Instill one drop into each eye 4 times a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (vehicle) | Placebo comparator | Not described Receives: Drug: Placebo (vehicle) |
| Rebamipide 2% ophthalmic suspension | Experimental | Not described Receives: Drug: Rebamipide 2% ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary ocular sign: Fluorescein corneal staining total score
Measured: 4 weeks
Primary ocular symptom: Worst ocular symptom severity score
Measured: 4 weeks
Secondary outcomes (2)
Fluorescein corneal staining total score
Measured: 2 weeks
Worst ocular symptom severity score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 564 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
- Acucela Medical Monitor, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632137
- Sponsor's protocol ID
- ACU-RED-301
- Status last verified
- Apr 2014
- First submitted
- 28 Jun 2012
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01632137
- Acronym / sponsor ID
- ACU-RED-301
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 2 Jul 2012 (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 efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
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 |
|---|---|---|
| Placebo (vehicle) | Placebo comparator | Drug: Placebo (vehicle) |
| Rebamipide 2% ophthalmic suspension | Experimental | Drug: Rebamipide 2% ophthalmic suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of dry eye-related ocular symptoms for at least 20 months.
- Meet protocol-defined criteria for corneal and conjunctival staining.
- Meet protocol-defined criteria for ocular discomfort.
Key exclusion criteria (5 listed)
- Active anterior segment ocular disease other than dry eye syndrome.
- Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
- Inability to suspend the use of contact lenses for the duration of the study.
- Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
- Received any other investigational product within 4 months before the screening visit.
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 into each eye 4 times a day for 4 weeks. | Drug | Rebamipide 2% ophthalmic suspension |
| Placebo (vehicle)Instill one drop into each eye 4 times a day for 4 weeks. | Drug | Placebo (vehicle) |
Primary outcome
Primary ocular sign: Fluorescein corneal staining total score
Time frame: 4 weeks
Primary ocular symptom: Worst ocular symptom severity score
Time frame: 4 weeks
2 secondary outcomes
Fluorescein corneal staining total score
Time frame: 2 weeks
Worst ocular symptom severity score
Time frame: 2 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 7 May 2014.
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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.
Acucela Medical Monitor study director
Kubota Vision Inc.
34 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 Rebamipide 2% ophthalmic suspension in people with Dry Eye Syndrome, run by Kubota Vision Inc. at 34 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 5 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 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?
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?
Primary ocular sign: Fluorescein corneal staining total score (time frame: 4 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 7 May 2014.