CataractsPhase 4NCT01021761
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
A Phase 4 study testing Ketorolac Tromethamine, Bromfenac and nepafenac in people with Cataracts, run by Frank A. Bucci, Jr., M.D..
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, Bromfenac and nepafenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- 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
- Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month
- No ocular use of prostaglandins within 2 weeks of surgery
- Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
- Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Active ocular infection
About this study
Official title: A Comparison of Prostaglandin E2 (PGE2) Inhibition 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 0.15cc 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, Bromfenac, nepafenac
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called Acuvail
ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
BromfenacDrug
Also called Xibrom
Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
nepafenacDrug
Also called Nevanac
drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Xibrom | Active comparator | Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery Receives: Drug: Bromfenac |
| Nevanac | Active comparator | Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery Receives: Drug: nepafenac |
| Acuvail | Active comparator | Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery. Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous PGE2 Inhibition
A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.
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 posted30 Nov 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021761
- Sponsor's protocol ID
- 2009 0199
- Status last verified
- Aug 2011
- First submitted
- 25 Nov 2009
- Last updated
- 31 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 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification
- ClinicalTrials.gov ID
- NCT01021761
- 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
- 30 Nov 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 0.15cc 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 |
|---|---|---|
| Xibrom | Active comparator | Drug: BromfenacXibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| Nevanac | Active comparator | Drug: nepafenacNevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| Acuvail | Active comparator | Drug: Ketorolac TromethamineAcuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to 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
- Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month
- No ocular use of prostaglandins within 2 weeks of surgery
- Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
- Contraindications to nonsteroidal anti-inflammatory drugs (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 TromethamineAlso: Acuvailketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Drug | Acuvail |
| BromfenacAlso: XibromDrug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Drug | Xibrom |
| nepafenacAlso: Nevanacdrug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Drug | Nevanac |
Primary outcome
Aqueous PGE2 Inhibition
Time frame: Day 4 of treatment
A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cataracts
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Tromethamine, Bromfenac and nepafenac in people with Cataracts, run by Frank A. Bucci, Jr., M.D..
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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Aqueous PGE2 Inhibition (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 31 Aug 2011.