Intraocular PressurePhase 4NCT00828477
Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
A Phase 4 study testing Xibrom and Nevanac in people with Intraocular Pressure, run by Bp Consulting, Inc at 1 site in United States.
Trial summary
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Xibrom and Nevanac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old, either gender or any race.
- Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
- Completion of written and informed consent/authorization prior to any study related procedures.
- Able to follow study protocol and likely to complete study schedule.
Who cannot join
- Known sensitivity to NSAIDs.
- History of neovascular or ocular inflammatory disease.
- Current use of topical or systemic anti-inflammatory medications.
- Females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
Coburn-Kleinfeldt Eye Clinic
3340 6 Mile Rd Livonia, Michigan, 48152
About this study
Official title: Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.
Read the detailed description
Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.
- Conditions
- Intraocular Pressure
- Being tested
- Xibrom, Nevanac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XibromDrug
Also called bromfenac
Xibrom: two times a day for seven days in the first eye.
NevanacDrug
Also called nepafenac
Nevanac: three times a day for seven days in the second eye.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Xibrom (bromfenac) Receives: Drug: Xibrom |
| 2 | Active comparator | Nevanac (nepafenac) Receives: Drug: Nevanac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of study medication
Measured: 28 days
Secondary outcomes (2)
Intraocular pressure changes
Measured: 28 days
Visual Acuity
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Investigators
- Nate Kleinfeldt, M.D, Principal investigator, Coburn-Kleinfeldt Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828477
- Sponsor's protocol ID
- 2009-0144
- Status last verified
- Jun 2009
- First submitted
- 14 Jan 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
- ClinicalTrials.gov ID
- NCT00828477
- Acronym / sponsor ID
- 2009-0144
- Conditions
- Intraocular Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Jan 2009 (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 evaluate and compare the comfort of bromfenac or nepafenac following SLT.
Detailed description
Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: XibromXibrom (bromfenac) |
| 2 | Active comparator | Drug: NevanacNevanac (nepafenac) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old, either gender or any race.
- Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
- Completion of written and informed consent/authorization prior to any study related procedures.
- Able to follow study protocol and likely to complete study schedule.
Key exclusion criteria (4 listed)
- Known sensitivity to NSAIDs.
- History of neovascular or ocular inflammatory disease.
- Current use of topical or systemic anti-inflammatory medications.
- Females of childbearing potential.
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 |
|---|---|---|
| XibromAlso: bromfenacXibrom: two times a day for seven days in the first eye. | Drug | 1 |
| NevanacAlso: nepafenacNevanac: three times a day for seven days in the second eye. | Drug | 2 |
Primary outcome
Tolerability of study medication
Time frame: 28 days
2 secondary outcomes
Intraocular pressure changes
Time frame: 28 days
Visual Acuity
Time frame: 28 days
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 10 Jun 2009.
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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.
Nate Kleinfeldt, M.D principal investigator
Coburn-Kleinfeldt Eye Clinic
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 Xibrom and Nevanac in people with Intraocular Pressure, 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 4 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 10 Jun 2009. 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?
Tolerability of study medication (time frame: 28 days). 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 10 Jun 2009.