Dry Eye DiseasePhase 4NCT00520260
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
A Phase 4 study testing bromfenac and ketorolac in people with Dry Eye Disease and Ocular Comfort, run by Florida Eye Microsurgical Institute at 1 site in United States.
Trial summary
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Ocular Comfort
- What is being tested?
- bromfenac and ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 4
- 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
- Must be in general good health
- Diagnosis of moderate to severe dry eye syndrome
Who cannot join
- Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
- Patients who are pregnant or nursing females
- Unwilling to discontinue use of contact lenses during the run-in and duration of the study
- Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
- Previous treatment failure on CSA 0.05% (Restasis)
- Known hypersensitivity to any component of the study or procedural medications
Show all 9Show fewer
- Participation in any other clinical trial within 30 days prior to screening
- Known contraindication to any study medication or any of their components.
- Should not be taking any oral anti-histamines, beta blockers or diuretics.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Eye Microsurgical Institute
Boynton Beach, Florida, 33426
About this study
Official title: Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
- Conditions
- Dry Eye Disease, Ocular Comfort
- Being tested
- bromfenac, ketorolac
- 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.
bromfenacDrug
0.09%, BID, 6 weeks
ketorolacDrug
0.4%, BID, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active treatment arm bromfenac 0.09% BID for 6 weeks Receives: Drug: bromfenac |
| 2 | Active comparator | ketorolac 0.4% BID for 6 weeks Receives: Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular comfort
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Eye Microsurgical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Barry Schechter, MD, Principal investigator, Florida Eye Microsurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520260
- Sponsor's protocol ID
- Sch012007
- Status last verified
- Feb 2009
- First submitted
- 21 Aug 2007
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
- ClinicalTrials.gov ID
- NCT00520260
- Acronym / sponsor ID
- Sch012007
- Conditions
- Dry Eye Disease, Ocular Comfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Florida Eye Microsurgical InstituteUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Aug 2007 (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.
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: bromfenacActive treatment arm bromfenac 0.09% BID for 6 weeks |
| 2 | Active comparator | Drug: ketorolacketorolac 0.4% BID for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be in general good health
- Diagnosis of moderate to severe dry eye syndrome
Key exclusion criteria (9 listed)
- Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
- Patients who are pregnant or nursing females
- Unwilling to discontinue use of contact lenses during the run-in and duration of the study
- Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
- Previous treatment failure on CSA 0.05% (Restasis)
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 |
|---|---|---|
| bromfenac0.09%, BID, 6 weeks | Drug | 1 |
| ketorolac0.4%, BID, 6 weeks | Drug | 2 |
Primary outcome
Ocular comfort
Time frame: six 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 19 Feb 2009.
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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.
Barry Schechter, MD principal investigator
Florida Eye Microsurgical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bromfenac and ketorolac in people with Dry Eye Disease and Ocular Comfort, run by Florida Eye Microsurgical Institute at 1 site 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 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 19 Feb 2009. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Ocular comfort (time frame: six 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 19 Feb 2009.