PainPhase 3NCT00853970
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
A Phase 3 study testing Bromfenac Ophthalmic Solution in people with Pain and Inflammation, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- Bromfenac Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
Who cannot join
- Have known hypersensitivity to bromfenac or to any component of the investigational product
Trial locations and contacts
1 site in 1 country.
United States1 site
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618
About this study
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
- Conditions
- Pain, Inflammation
- Being tested
- Bromfenac Ophthalmic Solution, Placebo Comparator
- Keywords
- Pain and Inflammation as a function of cataract surgery
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac Ophthalmic SolutionDrug
sterile ophthalmic solution
Placebo ComparatorDrug
sterile ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac ophthalmic solution 0.09% | Experimental | dosed 1 drop daily in study eye for 2 weeks Receives: Drug: Bromfenac Ophthalmic Solution |
| Placebo | Placebo comparator | dosed 1 drop daily in study eye for 2 weeks Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
Measured: Day 15 (Primary Endpoint)
Secondary outcomes (1)
Pain Free
Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim McNamara, PharmD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853970
- Sponsor's protocol ID
- CL-S&E-1205081-P
- Status last verified
- Jan 2013
- First submitted
- 26 Feb 2009
- Last updated
- 25 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
PubMed 21751945
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT00853970
- Acronym / sponsor ID
- CL-S&E-1205081-P
- Conditions
- Pain, Inflammation
- Keywords
- Pain and Inflammation as a function of cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 26 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromfenac ophthalmic solution 0.09% | Experimental | Drug: Bromfenac Ophthalmic Solutiondosed 1 drop daily in study eye for 2 weeks |
| Placebo | Placebo comparator | Drug: Placebo Comparatordosed 1 drop daily in study eye for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
Key exclusion criteria (1 listed)
- Have known hypersensitivity to bromfenac or to any component of the investigational product
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 |
|---|---|---|
| Bromfenac Ophthalmic Solutionsterile ophthalmic solution | Drug | Bromfenac ophthalmic solution 0.09% |
| Placebo Comparatorsterile ophthalmic solution | Drug | Placebo |
Primary outcome
Summed Ocular Inflammation Score (SOIS) of Zero
Time frame: Day 15 (Primary Endpoint)
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
1 secondary outcome
Pain Free
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21751945Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
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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.
Tim McNamara, PharmD study director
ISTA Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromfenac Ophthalmic Solution in people with Pain and Inflammation, run by Bausch & Lomb Incorporated 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 1 inclusion and 1 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 Jan 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jan 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?
Summed Ocular Inflammation Score (SOIS) of Zero (time frame: Day 15 (Primary Endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00853970, which also lists 1 linked publication.
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 Jan 2013.