CataractPhase 4NCT00347503
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
A Phase 4 study testing ketorolac 0.4%, bromfenac 0.09% in people with Cataract, run by Innovative Medical at 1 site in United States.
Trial summary
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ketorolac 0.4%, bromfenac 0.09%
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Male/Female 21 years of age of older.
- Patient understands and is willing to sign the written informed consent form
- Likely to complete the entire course of the study.
- Patient is scheduled to undergo cataract surgery
- Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
- Patient is willing and able to administer eye drops and record the times the drops were instilled
Who cannot join
- Patient has been using a topical NSAID within 1 week of study entry
- Patient has a known sensitivity to any of the ingredients in the study medications
- Patient has sight in only one eye
- Patient has a history of previous intraocular surgery
- Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
- Female patients who are pregnant, nursing an infant or planning a pregnancy
- Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.
- Conditions
- Cataract
- Being tested
- ketorolac 0.4%, bromfenac 0.09%
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolac 0.4%, bromfenac 0.09%Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Bucci, Principal investigator, Bucci Vision Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347503
- Sponsor's protocol ID
- B2601
- Status last verified
- Jul 2007
- First submitted
- 29 Jun 2006
- Last updated
- 13 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
- ClinicalTrials.gov ID
- NCT00347503
- Acronym / sponsor ID
- B2601
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 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.
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy Male/Female 21 years of age of older.
- Patient understands and is willing to sign the written informed consent form
- Likely to complete the entire course of the study.
- Patient is scheduled to undergo cataract surgery
- Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
Key exclusion criteria (7 listed)
- Patient has been using a topical NSAID within 1 week of study entry
- Patient has a known sensitivity to any of the ingredients in the study medications
- Patient has sight in only one eye
- Patient has a history of previous intraocular surgery
- Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
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 |
|---|---|---|
| ketorolac 0.4%, bromfenac 0.09% | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Jul 2007.
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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.
Frank Bucci principal investigator
Bucci Vision Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketorolac 0.4%, bromfenac 0.09% in people with Cataract, run by Innovative Medical 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 6 inclusion and 7 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 13 Jul 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
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 13 Jul 2007.