Dry Eye SyndromesPhase 2NCT01027013
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
A Phase 2 study testing rebamipide 2% ophthalmic suspension in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kubota Vision Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- rebamipide 2% ophthalmic suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2009to Nov 2010
- 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
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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ora, Inc
Andover, Massachusetts, 01810
Central Maine Eye Care
Lewiston, Maine, 04240
Richard Eiferman, MD
Louisville, Kentucky, 40205
Total Eye Care, P.A.
Memphis, Tennessee, 38119
The Eye Care Group, P.C.
Waterbury, Connecticut, 06708
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 for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- rebamipide 2% ophthalmic suspension, placebo eye drops
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
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.
Total fluorescein corneal staining score
Measured: 4 weeks
Primary ocular discomfort
Measured: 4 weeks
Secondary outcomes (2)
Dry eye symptoms
Measured: 12 weeks
Ocular staining
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 posted7 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- 220 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
- Nancy Boman, MD, PhD, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027013
- Sponsor's protocol ID
- ACU-RED-203
- Status last verified
- Jan 2012
- First submitted
- 4 Dec 2009
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- 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 for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
- ClinicalTrials.gov ID
- NCT01027013
- Acronym / sponsor ID
- ACU-RED-203
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Dec 2009 (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 rebamipide 2% suspension for the treatment of patients with dry-eye.
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 (2 listed)
- Age 18 years and older
- Diagnosis of dry eye as defined by the protocol
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
Total fluorescein corneal staining score
Time frame: 4 weeks
Primary ocular discomfort
Time frame: 4 weeks
2 secondary outcomes
Dry eye symptoms
Time frame: 12 weeks
Ocular staining
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.
Nancy Boman, MD, PhD study director
Kubota Vision Inc.
5 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 Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kubota Vision Inc. at 5 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 2 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 5 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?
Total fluorescein corneal staining 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 11 Jan 2012.