InflammationPhase 1/2NCT00431028
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
A Phase 1/2 study testing slow delivery ciprofloxacin + triamcinolone in people with Inflammation and Bacterial Infections, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Inflammation, Bacterial Infections
- What is being tested?
- slow delivery ciprofloxacin + triamcinolone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2005to Mar 2008
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with uncomplicated, senile cataract
- Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye
Who cannot join
- Patients in use of oral or topical anti-inflammatory agents
- History of steroid-induced ocular hypertension
- Hypermature cataracts
- Previous ocular surgery
- Preexisting uveitis
- Diabetic retinopathy
- Glaucoma
- Corneal disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Ophthalmology, Federal University of Sao Paulo
São Paulo, São Paulo, 04023-062
About this study
Official title: Phase I/II Comparative Study of a Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1% Prednisolone and 0.3% Ciprofloxacin Eyedrops for Cataract Surgery
The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.
Read the detailed description
Topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. Injection of depot corticosteroids into sub-Tenon's capsule is an established method of treating various ocular inflammatory diseases. Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation.
The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. Exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. In theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.
- Conditions
- Inflammation, Bacterial Infections
- Being tested
- slow delivery ciprofloxacin + triamcinolone
- Keywords
- Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems
- Medical subject headings
- Inflammation, Bacterial Infections, Cataract, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow delivery ciprofloxacin + triamcinoloneDevice
Also called ciprofloxacin, triamcinolona
2 mg ciprofloxacin + 25mg triamcinolone
| Study group | Role | What they receive |
|---|---|---|
| colirio | No intervention | prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops Receives: Device: slow delivery ciprofloxacin + triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber cell
Measured: Days 1, 3, 7, 14, and 28 after surgery
Anterior chamber flare
Measured: Days 1, 3, 7, 14, and 28 after surgery
Intraocular pressure
Measured: Days 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory response
Measured: Days 1, 3, 7, 14, and 28 after surgery
Presence of infection
Measured: Days 1, 3, 7, 14, and 28 after surgery
Secondary outcomes (2)
Conjunctival hyperemia
Measured: Days 1, 3, 7, 14, and 28 after surgery
Spectacle corrected visual acuity
Measured: Day 28 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionMar 2008
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Fernando Paganelli, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431028
- Sponsor's protocol ID
- Duocat 001
- Status last verified
- Mar 2008
- First submitted
- 1 Feb 2007
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paganelli F, Cardillo JA, Melo LA Jr, Lucena DR, Silva AA Jr, Oliveira AG, Hofling-Lima AL, Nguyen QD, Kuppermann BD, Belfort R Jr; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3041-7. doi: 10.1167/iovs.08-2920. Epub 2009 Feb 21.
PubMed 19234342
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Comparative Study of a Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1% Prednisolone and 0.3% Ciprofloxacin Eyedrops for Cataract Surgery
- ClinicalTrials.gov ID
- NCT00431028
- Acronym / sponsor ID
- Duocat 001
- Conditions
- Inflammation, Bacterial Infections
- Keywords
- Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Feb 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 one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.
Detailed description
Topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. Injection of depot corticosteroids into sub-Tenon's capsule is an established method of treating various ocular inflammatory diseases. Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation.
The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. Exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. In theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colirio | No intervention | Device: slow delivery ciprofloxacin + triamcinoloneprednisolone 1% eye drops + ciprofloxacin 0,3% eye drops |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with uncomplicated, senile cataract
- Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye
Key exclusion criteria (8 listed)
- Patients in use of oral or topical anti-inflammatory agents
- History of steroid-induced ocular hypertension
- Hypermature cataracts
- Previous ocular surgery
- Preexisting uveitis
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 |
|---|---|---|
| slow delivery ciprofloxacin + triamcinoloneAlso: ciprofloxacin, triamcinolona2 mg ciprofloxacin + 25mg triamcinolone | Device | colirio |
Primary outcome
Anterior chamber cell
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Anterior chamber flare
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Intraocular pressure
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory response
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Presence of infection
Time frame: Days 1, 3, 7, 14, and 28 after surgery
2 secondary outcomes
Conjunctival hyperemia
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Spectacle corrected visual acuity
Time frame: Day 28 after surgery
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
- Derived from this study: PubMed 19234342Paganelli F, Cardillo JA, Melo LA Jr, Lucena DR, Silva AA Jr, Oliveira AG, Hofling-Lima AL, Nguyen QD, Kuppermann BD, Belfort R Jr; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3041-7. doi: 10.1167/iovs.08-2920. Epub 2009 Feb 21.
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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.
Fernando Paganelli, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing slow delivery ciprofloxacin + triamcinolone in people with Inflammation and Bacterial Infections, run by Federal University of São Paulo at 1 site in Brazil.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Mar 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Anterior chamber cell (time frame: Days 1, 3, 7, 14, and 28 after surgery). The study lists 5 primary outcomes in all. 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 NCT00431028, which also lists 1 linked publication.
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 7 Mar 2008.