Cataract SurgeryPhase 2NCT00585975
Efficacy and Safety of Bromfenac Ophthalmic Solution
A Phase 2 study testing bromfenac ophthalmic solution in people with Cataract Surgery, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This is a safety and efficacy study of bromfenac ophthalmic solution Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- bromfenac ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2008
- Phase
- Phase 2
- 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
- Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery
Who cannot join
- Active corneal pathology in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618
About this study
This is a safety and efficacy study of bromfenac ophthalmic solution
- Conditions
- Cataract Surgery
- Being tested
- bromfenac ophthalmic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bromfenac ophthalmic solutionDrug
sterile opthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | Experimental | Not described Receives: Drug: bromfenac ophthalmic solution |
| Xibrom 0.09% | Experimental | Not described Receives: Drug: bromfenac ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
Measured: Day 15
Secondary outcomes (1)
Number of Participants That Are Pain Free
Participant description of being pain free taken from patient questionnaire with multiple possible responses
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 posted4 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
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 Cataract SurgeryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 568 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
- NCT00585975
- Sponsor's protocol ID
- CL-S&E-0802071-P
- Status last verified
- Feb 2013
- First submitted
- 21 Dec 2007
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bromfenac Ophthalmic Solution
- ClinicalTrials.gov ID
- NCT00585975
- Acronym / sponsor ID
- CL-S&E-0802071-P
- Conditions
- Cataract Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 9 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of bromfenac ophthalmic solution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | Experimental | Drug: bromfenac ophthalmic solution |
| Xibrom 0.09% | Experimental | Drug: bromfenac ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery
Key exclusion criteria (1 listed)
- Active corneal pathology in either eye
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 opthalmic solution | Drug | Bromfenac Ophthalmic Solution 0.18%, Xibrom 0.09% |
Primary outcome
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Time frame: Day 15
Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
1 secondary outcome
Number of Participants That Are 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 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 study testing bromfenac ophthalmic solution in people with Cataract Surgery, 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 15 Feb 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Dec 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?
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero (time frame: Day 15). 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 Feb 2013.