CataractPhase 4NCT00469690
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
A Phase 4 study testing Acular, Xibrom in people with Cataract, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Acular, Xibrom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2008
- 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
- Healthy volunteers accepted
- 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 Institute and Ambulatory Surgery Center
Wilkes-Barre, Pennsylvania, 18702
About this study
The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.
- Conditions
- Cataract
- Being tested
- Acular, Xibrom
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acular, XibromDrug
- Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
- Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Acular, Xibrom |
| 2 | Other | Not described Receives: Drug: Acular, Xibrom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous concentrations
Measured: 8 months
Secondary outcomes (1)
PGE2 Inhibition
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionMay 2008
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
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Bucci, MD, Principal investigator, Bucci Laser Vision Institute and Ambulatory Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469690
- Sponsor's protocol ID
- 5305
- Status last verified
- May 2008
- First submitted
- 2 May 2007
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. 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: Trough Drug Effects
- ClinicalTrials.gov ID
- NCT00469690
- Acronym / sponsor ID
- 5305
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 May 2007 (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 purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Acular, Xibrom |
| 2 | Other | Drug: Acular, Xibrom |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Acular, Xibrom1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am) 2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm) | Drug | 1, 2 |
Primary outcome
Aqueous concentrations
Time frame: 8 months
1 secondary outcome
PGE2 Inhibition
Time frame: 8 months
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 20 May 2008.
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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, MD principal investigator
Bucci Laser Vision Institute and Ambulatory Surgery 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 Acular, Xibrom 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 20 May 2008. 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.
What does the primary outcome measure?
Aqueous concentrations (time frame: 8 months). 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 20 May 2008.