Post Operative Anterior Chamber Inflammation (Flare)Phase 4NCT01023724
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
A Phase 4 study testing Ketorolac Tromethamine 0.45% and Bromfenac 0.09% in people with Post Operative Anterior Chamber Inflammation (Flare), run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Anterior Chamber Inflammation (Flare)
- What is being tested?
- Ketorolac Tromethamine 0.45% and Bromfenac 0.09%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years of age or older
- Scheduled for cataract surgery by phacoemulsification
- Subject must be willing to comply with all study requirements and be willing to give informed consent
Who cannot join
- Any subject that has a history of uveitis or active iritis
- Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months
- No ocular use of prostaglandins within 2 weeks of surgery
- Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery
- Contraindications to NSAIDs
- Active ocular infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.
- Being tested
- Ketorolac Tromethamine 0.45%, Bromfenac 0.09%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Tromethamine 0.45%Drug
Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.
Bromfenac 0.09%Drug
Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
| Study group | Role | What they receive |
|---|---|---|
| bromfenac 0.09% | Active comparator | bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. Receives: Drug: Bromfenac 0.09% |
| Acuvail | Active comparator | Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. Receives: Drug: Ketorolac Tromethamine 0.45% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Inflammation (Flare)
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Measured: Day 14 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionFeb 2010
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 Post Operative Anterior Chamber Inflammation (Flare)Studies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Frank A Bucci, Jr., MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023724
- Sponsor's protocol ID
- 2009-11-06 1
- Status last verified
- Jul 2011
- First submitted
- 1 Dec 2009
- Last updated
- 26 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
- ClinicalTrials.gov ID
- NCT01023724
- Acronym / sponsor ID
- 2009-11-06 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 26 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bromfenac 0.09% | Active comparator | Drug: Bromfenac 0.09%bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. |
| Acuvail | Active comparator | Drug: Ketorolac Tromethamine 0.45%Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be 18 years of age or older
- Scheduled for cataract surgery by phacoemulsification
- Subject must be willing to comply with all study requirements and be willing to give informed consent
Key exclusion criteria (6 listed)
- Any subject that has a history of uveitis or active iritis
- Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months
- No ocular use of prostaglandins within 2 weeks of surgery
- Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery
- Contraindications to NSAIDs
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 |
|---|---|---|
| Ketorolac Tromethamine 0.45%Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days. | Drug | Acuvail |
| Bromfenac 0.09%Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively | Drug | bromfenac 0.09% |
Primary outcome
Anterior Chamber Inflammation (Flare)
Time frame: Day 14 of treatment
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- 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.
Frank A Bucci, Jr., MD principal investigator
Bucci Laser Vision 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 Ketorolac Tromethamine 0.45% and Bromfenac 0.09% in people with Post Operative Anterior Chamber Inflammation (Flare), run by Bucci Laser Vision 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 3 inclusion and 6 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 26 Aug 2011. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2011). 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?
Anterior Chamber Inflammation (Flare) (time frame: Day 14 of treatment). 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 26 Aug 2011.