CataractsPhase 4NCT00758199
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
A Phase 4 study testing Bromfenac, Moxifloxacin hydrochloride and Prednisolone Acetate in people with Cataracts, run by Bp Consulting, Inc at 1 site in United States.
Trial summary
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataracts
- What is being tested?
- Bromfenac, Moxifloxacin hydrochloride and Prednisolone Acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >18 years of age scheduled to undergo bilateral cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively
- Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Who cannot join
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
- Conditions
- Cataracts
- Being tested
- Bromfenac, Moxifloxacin hydrochloride, Prednisolone Acetate
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
Also called Bromfenac (Xibrom)
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
Moxifloxacin hydrochlorideDrug
Also called Moxifloxacin hydrochloride (Vigamox)
Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
Prednisolone AcetateDrug
Also called Omni-Pred
Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Moxifloxacin Receives: Drug: Moxifloxacin hydrochloride |
| 3 | Placebo comparator | Prednisolone Acetate Receives: Drug: Prednisolone Acetate |
| 1 | Active comparator | Bromfenac Receives: Drug: Bromfenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT with macular thickening
Measured: 3-6 weeks
Secondary outcomes (1)
Incidence of CME
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758199
- Sponsor's protocol ID
- 2008-0036
- Status last verified
- Mar 2012
- First submitted
- 22 Sep 2008
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT00758199
- Acronym / sponsor ID
- 2008-0036
- Conditions
- Cataracts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Sep 2008 (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 objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Moxifloxacin hydrochlorideMoxifloxacin |
| 3 | Placebo comparator | Drug: Prednisolone AcetatePrednisolone Acetate |
| 1 | Active comparator | Drug: BromfenacBromfenac |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female >18 years of age scheduled to undergo bilateral cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively
- Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Key exclusion criteria (5 listed)
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
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 |
|---|---|---|
| BromfenacAlso: Bromfenac (Xibrom)Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks | Drug | 1 |
| Moxifloxacin hydrochlorideAlso: Moxifloxacin hydrochloride (Vigamox)Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery. | Drug | 2 |
| Prednisolone AcetateAlso: Omni-PredGroup 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD). | Drug | 3 |
Primary outcome
OCT with macular thickening
Time frame: 3-6 weeks
1 secondary outcome
Incidence of CME
Time frame: 3-6 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 15 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Moxifloxacin hydrochloride and Prednisolone Acetate in people with Cataracts, run by Bp Consulting, Inc 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 4 inclusion and 5 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 15 Mar 2012. 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. 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 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?
OCT with macular thickening (time frame: 3-6 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 15 Mar 2012.