Postoperative ComplicationsPhase 3NCT00198445
Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
A Phase 3 study testing Bromfenac in people with Postoperative Complications and Cataract, run by Bausch & Lomb Incorporated at 39 sites in United States.
Trial summary
The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation 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
- Postoperative Complications, Cataract
- What is being tested?
- Bromfenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 527 participants
- Where
- 39 sitesUnited States
- Study dates
- May 2003to Jan 2004
- 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
- Cataract surgery
- Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
- Agreed to avoid disallowed medications (meds) throughout the duration of the study
Who cannot join
- Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
- Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
- Extraocular/intraocular inflammation in either eye
- Clinically significant (WHO CTC Grade 1 or greater) liver function tests
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Arthur J Weinstein, MD
Albuquerque, New Mexico, 87102
Texan Eye Care PA
Austin, Texas, 78705
Harold A Helms, MD
Birmingham, Alabama, 35205
Cohen Laser Vision Center
Boca Raton, Florida, 33431
Cornea Consultants
Boston, Massachusetts, 02114
Brandon Cataract Center & Eye Clinic
Brandon, Florida, 33511
Horizon Eye Care
Charlotte, North Carolina, 28211
Middle Tennessee Eye Associates
Cookeville, Tennessee, 38501
Cincinnati Eye Institute NKY
Edgewood, Kentucky, 41017
Advanced Eye Care, PC
Fort Oglethorpe, Georgia, 30742
Ophthalmology Service, Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Ophthalmology Visual Science
Galveston, Texas, 77555
Donald E Beahm, MD
Great Bend, Kansas, 67530
Houston Eye Associates
Houston, Texas, 77025
UCI, Department of Ophthalmology
Irvine, California, 92697
Hunkeler Eye Institute
Kansas City, Missouri, 64111
Eye Care Arkansas, PA
Little Rock, Arkansas, 72205
E Randy Craven, MD
Littleton, Colorado, 80120
Saltzer Medical Group, PA
Nampa, Idaho, 83686
The Eye Care Group
New Haven, Connecticut, 06510
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Stevenson Medical Surgical Eye Center
New Orleans, Louisiana, 70119
Anesthetic Eye Care Institute
Newport Beach, California, 92663
Virginia Eye Consultants
Norfolk, Virginia, 23507
Dean A McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104
Casey Eye Institute
Portland, Oregon, 97201
Eye Health Northwest
Portland, Oregon, 97209
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Richard A Lewis, MD
Sacramento, California, 95819
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
David G Shulman, MD
San Antonio, Texas, 78209
Eye Care of San Diego
San Diego, California, 92103
Santa Clara Valley Medical Center
San Jose, California, 95128
Central Texas Eye Center
San Marcos, Texas, 78666
Marvin E Greenberg, MD, PA
Tamarac, Florida, 33321
The Eye Institute
Tulsa, Oklahoma, 74104
Jack Daubert, MD
West Palm Beach, Florida, 33401
About this study
Official title: Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery
The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
- Conditions
- Postoperative Complications, Cataract
- Being tested
- Bromfenac, Placebo
- Keywords
- Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
- Medical subject headings
- Postoperative Complications, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
One drop in study eye every 12 hours for 14 days
PlaceboDrug
One drop in study eye every 12 hours for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac | Experimental | Topical bromfenac ophthalmic solution 0.1% Receives: Drug: Bromfenac |
| Placebo | Placebo comparator | Vehicle of bromfenac Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Inflammation Score
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
Measured: Visit 4 (Day 15)
Secondary outcomes (1)
Mean Ocular Inflammation Score
Mean change from baseline in SOIS at each visit.
Measured: At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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, Care provider
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa R Grillone, PhD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198445
- Sponsor's protocol ID
- ISTA-BR-CS001
- Status last verified
- Mar 2013
- First submitted
- 12 Sep 2005
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT00198445
- Acronym / sponsor ID
- ISTA-BR-CS001
- Conditions
- Postoperative Complications, Cataract
- Keywords
- Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 20 Sep 2005 (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 was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromfenac | Experimental | Drug: BromfenacTopical bromfenac ophthalmic solution 0.1% |
| Placebo | Placebo comparator | Drug: PlaceboVehicle of bromfenac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract surgery
- Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
- Agreed to avoid disallowed medications (meds) throughout the duration of the study
Key exclusion criteria (4 listed)
- Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
- Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
- Extraocular/intraocular inflammation in either eye
- Clinically significant (WHO CTC Grade 1 or greater) liver function tests
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 |
|---|---|---|
| BromfenacOne drop in study eye every 12 hours for 14 days | Drug | Bromfenac |
| PlaceboOne drop in study eye every 12 hours for 14 days | Drug | Placebo |
Primary outcome
Ocular Inflammation Score
Time frame: Visit 4 (Day 15)
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
1 secondary outcome
Mean Ocular Inflammation Score
Time frame: At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)
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 14 Mar 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.
Lisa R Grillone, PhD study director
ISTA Pharmaceuticals, Inc.
39 sites 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 in people with Postoperative Complications and Cataract, run by Bausch & Lomb Incorporated at 39 sites 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 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 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites 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?
Ocular Inflammation Score (time frame: Visit 4 (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 14 Mar 2013.