PainPhase 3NCT00333918
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With 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
The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation. 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
- 522 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2007
- Phase
- Phase 3
- 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
- Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
- Agree to return for all required visits
- Agree to avoid disallowed medications
Who cannot join
- Known hypersensitivity to bromfenac and salicylates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.
- Conditions
- Pain, Inflammation
- Being tested
- bromfenac ophthalmic solution, placebo comparator
- Keywords
- Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
- 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
placebo comparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 1-bromfenac ophthalmic solution | Experimental | sterile ophthalmic solution Receives: Drug: bromfenac ophthalmic solution |
| 2-placebo comparator | Placebo comparator | sterile ophthalmic solution Receives: Drug: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ocular inflammation
Secondary outcomes (1)
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Bianca, PhD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333918
- Sponsor's protocol ID
- ISTA-BR-CS02
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2006
- Last updated
- 15 Feb 2013
- Results posted
- 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 Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT00333918
- Acronym / sponsor ID
- ISTA-BR-CS02
- Conditions
- Pain, Inflammation
- Keywords
- Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Jun 2006 (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 primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-bromfenac ophthalmic solution | Experimental | Drug: bromfenac ophthalmic solutionsterile ophthalmic solution |
| 2-placebo comparator | Placebo comparator | Drug: placebo comparatorsterile ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
- Agree to return for all required visits
- Agree to avoid disallowed medications
Key exclusion criteria (1 listed)
- Known hypersensitivity to bromfenac and salicylates
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 solution | Drug | 1-bromfenac ophthalmic solution |
| placebo comparator | Drug | 2-placebo comparator |
Primary outcome
Reduction of ocular inflammation
1 secondary outcome
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free
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 15 Feb 2013.
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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.
Ralph Bianca, PhD 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 3 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. 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?
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?
Reduction of ocular inflammation. 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.