CataractPhase 4NCT00392275
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
A Phase 4 study testing Ofloxacin 0.3%, Ciprofloxacin 0.3% and Levofloxacin 0.5% in people with Cataract, run by Indiana University at 3 sites in United States.
Trial summary
Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Ofloxacin 0.3%, Ciprofloxacin 0.3% and Levofloxacin 0.5%
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2002to May 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with functioning filtering blebs will be evaluated prospectively for inclusion
Who cannot join
- Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:
- Ongoing ocular inflammatory disease
- Bleb leakage - determined by Seidel test
- Suspected infection
- Known contraindications to use of any of these study medications.
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
Richard L Rodeboush VA Medical Center
Indianapolis, Indiana, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
About this study
Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.
Read the detailed description
The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.
- Conditions
- Cataract
- Being tested
- Ofloxacin 0.3%, Ciprofloxacin 0.3%, Levofloxacin 0.5%, Ofloxacin 400mg, Ciprofloxacin 400mg
- Keywords
- Cataract, Aqueous absorption, Funtioning Filtering Blebs
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ofloxacin 0.3%Drug
Ciprofloxacin 0.3%Drug
Levofloxacin 0.5%Drug
Ofloxacin 400mgDrug
Ciprofloxacin 400mgDrug
Levofloxacin 250mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous levels of antibiotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis B Cantor, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392275
- Sponsor's protocol ID
- 0208-29
- Status last verified
- Dec 2007
- First submitted
- 23 Oct 2006
- Last updated
- 10 Apr 2013
- Results posted
- No
Publications
Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
PubMed 11545629Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008 Mar;92(3):345-7. doi: 10.1136/bjo.2007.121541. Epub 2008 Jan 22.
PubMed 18211932
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
- ClinicalTrials.gov ID
- NCT00392275
- Acronym / sponsor ID
- 0208-29
- Conditions
- Cataract
- Keywords
- Cataract, Aqueous absorption, Funtioning Filtering Blebs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- May 2006 (actual)
- First posted
- 25 Oct 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.
Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.
Detailed description
The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with functioning filtering blebs will be evaluated prospectively for inclusion
Key exclusion criteria (6 listed)
- Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:
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 |
|---|---|---|
| Ofloxacin 0.3% | Drug | – |
| Ciprofloxacin 0.3% | Drug | – |
| Levofloxacin 0.5% | Drug | – |
| Ofloxacin 400mg | Drug | – |
| Ciprofloxacin 400mg | Drug | – |
| Levofloxacin 250mg | Drug | – |
Primary outcome
Aqueous levels of antibiotics
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 10 Apr 2013.
- Background: PubMed 11545629Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
- Derived from this study: PubMed 18211932Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008 Mar;92(3):345-7. doi: 10.1136/bjo.2007.121541. Epub 2008 Jan 22.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Louis B Cantor, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ofloxacin 0.3%, Ciprofloxacin 0.3% and Levofloxacin 0.5% in people with Cataract, run by Indiana University at 3 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 1 inclusion and 6 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 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 levels of antibiotics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392275, which also lists 2 linked publications.
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 10 Apr 2013.