CataractNCT00666042
Bioequivalence of Eye Drops and Spray Administration of Vigamox
A study testing Vigamox - administration in spray form and Vigamox eye drops in people with Cataract, run by Advanced Ophthalmic Pharma at 1 site in Israel.
Trial summary
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Vigamox - administration in spray form and Vigamox eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to May 2009
- 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 21 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
- Allergy to Vigamox
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.
- Conditions
- Cataract
- Being tested
- Vigamox - administration in spray form, Vigamox eye drops
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigamox - administration in spray formDrug
Vigamox will be administered in a spray form
Vigamox eye dropsDrug
Vigamox eye drops
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Vigamox delivered as spray Receives: Drug: Vigamox - administration in spray form |
| B | Active comparator | Patients will receive the commercially available Vigamox drops Receives: Drug: Vigamox eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalency between the 2 ways of administration
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionMay 2009
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, TAMC, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666042
- Sponsor's protocol ID
- Eye drops vs. spray
- Other IDs
- different administrations
- Status last verified
- Aug 2009
- First submitted
- 22 Apr 2008
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form
- ClinicalTrials.gov ID
- NCT00666042
- Acronym / sponsor ID
- Eye drops vs. spray
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Advanced Ophthalmic PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Apr 2008 (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 study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Vigamox - administration in spray formVigamox delivered as spray |
| B | Active comparator | Drug: Vigamox eye dropsPatients will receive the commercially available Vigamox drops |
Who may qualify
- Ages
- 21 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)
- Allergy to Vigamox
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 - administration in spray formVigamox will be administered in a spray form | Drug | A |
| Vigamox eye dropsVigamox eye drops | Drug | B |
Primary outcome
Bioequivalency between the 2 ways of administration
Time frame: 4 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 19 Jan 2012.
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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
TAMC, Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigamox - administration in spray form and Vigamox eye drops in people with Cataract, run by Advanced Ophthalmic Pharma at 1 site in Israel.
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: finished, as of the sponsor's last update on 19 Jan 2012. 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 Israel. 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?
Bioequivalency between the 2 ways of administration (time frame: 4 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 19 Jan 2012.