CataractPhase 4NCT01859702

Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients

A Phase 4 study testing Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution in people with Cataract, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract
What is being tested?: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Apr 2012to Aug 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Requires cataract surgery;
Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
Able to follow instructions and willing to attend all study visits;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
Use of medications, as specified in protocol;
Severe dry eye syndrome;
Use of contact lenses two days before surgery until the last visit;
External eye disease, infection or inflammation of the eyes or eyelids;

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Excessive bleeding tendency;
No vision in the eye not included in the study;
Pregnant or breastfeeding;
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Conditions: Cataract
Being tested: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Keywords: Aqueous Humor, Moxifloxacin, Vigadexa
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solutionDrug
Also called Vigadexa®

Study groups in NCT01859702
Study group	Role	What they receive
VIGADEXA	Experimental	Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure. Receives: Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Aqueous Humor Concentration of Moxifloxacin
A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.
Measured: Day 3 (operative day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Aug 2012

First posted22 May 2013 (estimated)
Study startApr 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859702
Sponsor's protocol ID: RDG-11-235
Status last verified: Jun 2013
First submitted: 20 May 2013
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
ClinicalTrials.gov ID: NCT01859702
Acronym / sponsor ID: RDG-11-235
Conditions: Cataract
Keywords: Aqueous Humor, Moxifloxacin, Vigadexa
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 7 Aug 2013

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 was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VIGADEXA	Experimental	Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solutionMoxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Requires cataract surgery;
Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
Able to follow instructions and willing to attend all study visits;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (10 listed)

Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
Use of medications, as specified in protocol;
Severe dry eye syndrome;
Use of contact lenses two days before surgery until the last visit;

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
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solutionAlso: Vigadexa®	Drug	VIGADEXA

Primary outcome

Mean Aqueous Humor Concentration of Moxifloxacin
Time frame: Day 3 (operative day)
A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.

Results and safety

Results posted to the registry on 7 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIGADEXA	36	31

Primary outcome: Mean Aqueous Humor Concentration of Moxifloxacin

Time frame: Day 3 (operative day). Mean (95% Confidence Interval). Unit: nanograms per milliliter

Measure	VIGADEXA n = 31
Value	1110.6 (857.5 to 1363.7)

Population analysed: Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.

Adverse events

Time frame: Adverse events were collected for the duration of the study. An adverse event was defined as any untoward medical occurrence, or deterioration of a pre-existing medical condition, that occurred during or after test product administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIGADEXA	0 of 36 (0%)	2 of 36 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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.

Abayomi Ogundele, PharmD study director

Alcon Research

Mauro Silveira de Queiroz Campos, MD principal investigator

Federal University of São Paulo, Ophthalmology Service

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution in people with Cataract, run by Alcon Research.

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 4 inclusion and 10 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 7 Aug 2013. 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.

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?

Yes. Results are posted in the registry (first posted 7 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Aqueous Humor Concentration of Moxifloxacin (time frame: Day 3 (operative day)). 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 NCT01859702.

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 Aug 2013.