PainPhase 3NCT01367249
Efficacy 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
This is an 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, Cataract
- What is being tested?
- Bromfenac Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- 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
Official title: Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.
This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.
- Conditions
- Pain, Inflammation, Cataract
- Being tested
- Bromfenac Ophthalmic Solution, Placebo
- Keywords
- cataract surgery
- Medical subject headings
- Pain, Inflammation, Cataract
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
PlaceboDrug
Sterile ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac Ophthalmic Solution | Experimental | Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Receives: Drug: Bromfenac Ophthalmic Solution |
| Placebo | Placebo comparator | One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Inflammation
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Measured: Day 15
Secondary outcomes (1)
Ocular Pain
The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.
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 posted7 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionDec 2011
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 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
- 440 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
- NCT01367249
- Sponsor's protocol ID
- S00124
- Status last verified
- Apr 2014
- First submitted
- 1 Jun 2011
- Last updated
- 6 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.
- ClinicalTrials.gov ID
- NCT01367249
- Acronym / sponsor ID
- S00124
- Conditions
- Pain, Inflammation, Cataract
- Keywords
- cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 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 | Experimental | Drug: Bromfenac Ophthalmic SolutionBromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
| Placebo | Placebo comparator | Drug: PlaceboOne drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
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 |
| PlaceboSterile ophthalmic solution | Drug | Placebo |
Primary outcome
Ocular Inflammation
Time frame: Day 15
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
1 secondary outcome
Ocular Pain
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 6 May 2014.
- 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 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 6 May 2014. 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 6 May 2014). 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?
Ocular Inflammation (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 6 May 2014.