CataractsPhase 4NCT01001806
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
A Phase 4 study testing Ketorolac Tromethamine 0.45%, bromfenac 0.09% and nepafenac 0.1% in people with Cataracts, run by Frank A. Bucci, Jr., M.D. at 1 site in United States.
Trial summary
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- What is being tested?
- Ketorolac Tromethamine 0.45%, bromfenac 0.09% and nepafenac 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 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 eye 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 ophthalmic steroids, nonsteroidal anti-inflammatory (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 Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
- Conditions
- Cataracts
- Being tested
- Ketorolac Tromethamine 0.45%, bromfenac 0.09%, nepafenac 0.1%
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Tromethamine 0.45%Drug
Also called Acuvail
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
bromfenac 0.09%Drug
Also called Xibrom
One day pre operative 1 drop BID then 3 doses pre op day of surgery
nepafenac 0.1%Drug
Also called Nevanac
One drop BID, 1 day pre operative and then 3 doses the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Acuvail | Active comparator | Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery Receives: Drug: Ketorolac Tromethamine 0.45% |
| Xibrom | Active comparator | Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery Receives: Drug: bromfenac 0.09% |
| Nevanac | Active comparator | One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery Receives: Drug: nepafenac 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Aqueous Penetration
Measured: day 4 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionJan 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 CataractsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank A. Bucci, Jr., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
- Investigators
- Frank A Bucci, Jr.,, MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001806
- Sponsor's protocol ID
- 2009-0199
- Status last verified
- Aug 2011
- First submitted
- 23 Oct 2009
- Last updated
- 3 Oct 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 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
- ClinicalTrials.gov ID
- NCT01001806
- Acronym / sponsor ID
- 2009-0199
- Conditions
- Cataracts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Frank A. Bucci, Jr., M.D.University, hospital or other
- Collaborators
- Allergan
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Oct 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 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acuvail | Active comparator | Drug: Ketorolac Tromethamine 0.45%Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery |
| Xibrom | Active comparator | Drug: bromfenac 0.09%Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery |
| Nevanac | Active comparator | Drug: nepafenac 0.1%One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery |
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 eye 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 ophthalmic steroids, nonsteroidal anti-inflammatory (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%Also: AcuvailOne drop BID the day before surgery and then 3 doses the day of surgery prior to surgery | Drug | Acuvail |
| bromfenac 0.09%Also: XibromOne day pre operative 1 drop BID then 3 doses pre op day of surgery | Drug | Xibrom |
| nepafenac 0.1%Also: NevanacOne drop BID, 1 day pre operative and then 3 doses the day of surgery | Drug | Nevanac |
Primary outcome
Peak Aqueous Penetration
Time frame: day 4 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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%, bromfenac 0.09% and nepafenac 0.1% in people with Cataracts, run by Frank A. Bucci, Jr., M.D. 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 3 Oct 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?
Peak Aqueous Penetration (time frame: day 4 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 3 Oct 2011.