InflammationNCT01060787
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
An observational study of Inflammation and Uveitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Inflammation, Uveitis
- What is being tested?
- Fluocinolone Acetonide 0.59 mg and Fluocinolone Acetonide 2.1 mg
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2016to 7 Jun 2019
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.
Who may be able to join
- Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
- Able and willing to follow instructions
- Able and willing to provide informed consent
Who cannot join
- Is monocular
- Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
- Had bilateral FA intravitreal implants
- Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Partners of Boston
Boston, Massachusetts, 02114
About this study
Official title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
Read the detailed description
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.
- Conditions
- Inflammation, Uveitis
- Being tested
- Fluocinolone Acetonide 0.59 mg, Fluocinolone Acetonide 2.1 mg
- Medical subject headings
- Inflammation, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone Acetonide 0.59 mgProcedure or surgery
Also called Retisert
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Fluocinolone Acetonide 2.1 mgProcedure or surgery
Also called Retisert
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone Acetonide 0.59 mg | Participants who have had the fluocinolone acetonide (FA) drug delivery system 0.59 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. Receives: Procedure: Fluocinolone Acetonide 0.59 mg | |
| Fluocinolone Acetonide 2.1 mg | Participants who have had the fluocinolone acetonide (FA) drug delivery system 2.1 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. Receives: Procedure: Fluocinolone Acetonide 2.1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Endothelial Cell Density
Bilateral specular microscopy will be performed and endothelial cell density will be recorded.
Measured: 1 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study start4 Feb 2016
- Primary completion7 Mar 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Valeant Pharmaceuticals/Bausch & Lomb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060787
- Sponsor's protocol ID
- 440
- Status last verified
- Jun 2019
- First submitted
- 29 Jan 2010
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
- ClinicalTrials.gov ID
- NCT01060787
- Acronym / sponsor ID
- 440
- Conditions
- Inflammation, Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 2 Feb 2010 (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.
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
Detailed description
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone Acetonide 0.59 mg | – | Procedure: Fluocinolone Acetonide 0.59 mgParticipants who have had the fluocinolone acetonide (FA) drug delivery system 0.59 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. |
| Fluocinolone Acetonide 2.1 mg | – | Procedure: Fluocinolone Acetonide 2.1 mgParticipants who have had the fluocinolone acetonide (FA) drug delivery system 2.1 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.
Key inclusion criteria (3 listed)
- Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
- Able and willing to follow instructions
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Is monocular
- Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
- Had bilateral FA intravitreal implants
- Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete 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 |
|---|---|---|
| Fluocinolone Acetonide 0.59 mgAlso: RetisertAt a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density. | Procedure or surgery | Fluocinolone Acetonide 0.59 mg |
| Fluocinolone Acetonide 2.1 mgAlso: RetisertAt a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density. | Procedure or surgery | Fluocinolone Acetonide 2.1 mg |
Primary outcome
Corneal Endothelial Cell Density
Time frame: 1 Visit
Bilateral specular microscopy will be performed and endothelial cell density will be recorded.
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 21 Jun 2019.
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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.
Johnson Varughese study director
Valeant Pharmaceuticals/Bausch & Lomb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Uveitis, run by Bausch & Lomb Incorporated 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 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 21 Jun 2019. 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.
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?
Corneal Endothelial Cell Density (time frame: 1 Visit). 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 21 Jun 2019.