CataractNCT00565630
Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops
A study testing Vigamox delivered via the device in spray form in people with Cataract, run by Advanced Ophthalmic Pharma.
Trial summary
The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Vigamox delivered via the device in spray form
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2008
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cataract surgery
Who cannot join
- Known allergy to quinolone compounds
About this study
Official title: Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray
The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.
Read the detailed description
Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.
Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.
- Conditions
- Cataract
- Being tested
- Vigamox delivered via the device in spray form
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigamox delivered via the device in spray formDevice
Vigamox delivered 4 times, 1 hour prior to cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vigamox via the experiemntal device Receives: Device: Vigamox delivered via the device in spray form |
| 2 | Active comparator | Vigamox drops from the commercially available bottles Receives: Device: Vigamox delivered via the device in spray form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqeous concentration of Vigamox
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startJan 2008
- Study completionMar 2008 (estimated)
Why it stopped: Replaced with ongoing study
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Ophthalmic Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adi Michaeli, MD, Principal investigator, Dept of Ophthalmology, TAMC, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565630
- Sponsor's protocol ID
- Drops vs. spray administration
- Other IDs
- TAMC 06-306
- Status last verified
- Nov 2007
- First submitted
- 28 Nov 2007
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray
- ClinicalTrials.gov ID
- NCT00565630
- Acronym / sponsor ID
- Drops vs. spray administration
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with ongoing study
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Advanced Ophthalmic PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Study completion
- Mar 2008 (estimated)
- First posted
- 30 Nov 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 the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.
Detailed description
Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.
Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Vigamox delivered via the device in spray formVigamox via the experiemntal device |
| 2 | Active comparator | Device: Vigamox delivered via the device in spray formVigamox drops from the commercially available bottles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective cataract surgery
Key exclusion criteria (1 listed)
- Known allergy to quinolone compounds
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 |
|---|---|---|
| Vigamox delivered via the device in spray formVigamox delivered 4 times, 1 hour prior to cataract surgery | Device | 1, 2 |
Primary outcome
Aqeous concentration of Vigamox
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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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.
Adi Michaeli, MD principal investigator
Dept of Ophthalmology, TAMC, Tel Aviv, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Vigamox delivered via the device in spray form in people with Cataract, run by Advanced Ophthalmic Pharma.
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 1 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: withdrawn, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Aqeous concentration of Vigamox (time frame: one month). 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 25 Feb 2009; AzTrials last refreshed its copy on 28 Oct 2026.