Cystoid Macular Edema,Phase 4NCT00469781
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
A Phase 4 study testing 2. Xibrom (Bromfenac) and 1. Pred Forte in people with Cystoid Macular Edema, and Retinal Thickening, run by Center For Excellence In Eye Care at 1 site in United States.
Trial summary
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema,, Retinal Thickening
- What is being tested?
- 2. Xibrom (Bromfenac) and 1. Pred Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Sep 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
- · Male or female > 18 years of age scheduled to undergo cataract surgery
- Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
- Expected visual outcome of 20/25 or better.
- Ability to provide informed consent and likely to complete all study visits
Who cannot join
- · Known contraindication to any study medication or any of their components
- Uncontrolled systemic disease
- Required use of ocular medications other than the study medications during the study
- Abnormal pre-operative OCTs
- Diabetic patients with a history of macular edema or diabetic retinopathy
- AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
- Only one eye of each patient can be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Excellence in Eye Care
Miami, Florida, 33176
About this study
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.
- Conditions
- Cystoid Macular Edema,, Retinal Thickening
- Being tested
- 2. Xibrom (Bromfenac), 1. Pred Forte
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2. Xibrom (Bromfenac)Drug
Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
1. Pred ForteDrug
Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.
Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: 1. Pred Forte |
| 2 | Other | Not described Receives: Drug: 2. Xibrom (Bromfenac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystoid Macular Edema
Measured: 11 months
Secondary outcomes (1)
Retinal Thickening
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular Edema,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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center For Excellence In Eye Care
- Sponsor type
- University, hospital or other
- Investigators
- Carlos Buznego, MD, Principal investigator, The Center for Excellence in Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469781
- Sponsor's protocol ID
- 5306
- Status last verified
- Sep 2008
- First submitted
- 4 May 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
- ClinicalTrials.gov ID
- NCT00469781
- Acronym / sponsor ID
- 5306
- Conditions
- Cystoid Macular Edema,, Retinal Thickening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Center For Excellence In Eye CareUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 May 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.
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 1. Pred Forte |
| 2 | Other | Drug: 2. Xibrom (Bromfenac) |
Who may qualify
- Ages
- 18 years and older
- 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 cataract surgery
Key exclusion criteria (7 listed)
- · Known contraindication to any study medication or any of their components
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 |
|---|---|---|
| 2. Xibrom (Bromfenac)Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery. | Drug | 2 |
| 1. Pred ForteGroup 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks. Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks. | Drug | 1 |
Primary outcome
Cystoid Macular Edema
Time frame: 11 months
1 secondary outcome
Retinal Thickening
Time frame: 11 months
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 25 Sep 2008.
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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.
Carlos Buznego, MD principal investigator
The Center for Excellence in Eye Care
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 2. Xibrom (Bromfenac) and 1. Pred Forte in people with Cystoid Macular Edema, and Retinal Thickening, run by Center For Excellence In Eye Care 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 7 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 25 Sep 2008. 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?
Cystoid Macular Edema (time frame: 11 months). 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 25 Sep 2008.