Corneal HealthPhase 4STB-01NCT01455233
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
A Phase 4 study testing besivance and vigamox in people with Corneal Health and Cataract Surgery, run by Ophthalmology Consultants, Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Health, Cataract Surgery
- What is being tested?
- besivance and vigamox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Feb 2011
- Phase
- Phase 4
- 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
- Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery
- Patients who are able to understand and sign an informed consent form that has been approved by an IRB
Who cannot join
- Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism
- Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit
- History of or Fuch's Corneal Endothelial Dystrophy
- Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.
- Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)
- A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye
Show all 17Show fewer
- Currently diagnosed uncontrolled glaucoma in the operative eye
- Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye
- A visually nonfunctional fellow eye defined as a best corrected visual acuity </= 35 ETDRS letters (20/200 Snellen equivalent) or worse
- Participation in any other investigational drug or device study within 30 days before cataract surgery
- Known or suspected allergy or hypersensitivity to any component of either test article
- Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
- they are breast feeding
- they have a positive urine pregnancy test at screening
- they are not willing to undergo a urine pregnancy test upon entering or exiting the study
- they intend to become pregnant during the duration of the study; or,
- they do not agree to use adequate birth control methods for the duration of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ophthalmology Associates
St Louis, Missouri, 63131
Ophthalmology Consultants, Ltd
St Louis, Missouri, 63131
About this study
Official title: Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery
The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
Read the detailed description
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Conditions
- Corneal Health, Cataract Surgery
- Being tested
- besivance, vigamox
- Keywords
- cornea, ocular antibiotic, cataract surgery
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
besivanceDrug
Also called besifloxacin ophthalmic suspension 0.6%
topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery
vigamoxDrug
Also called moxifloxacin hydrochloride ophthalmic solution 0.5%
topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| besivance | Active comparator | ocular antibiotic Receives: Drug: vigamox |
| vigamox | Active comparator | ocular antibiotic Receives: Drug: besivance |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal health
Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)
Measured: through day 28 post op
Secondary outcomes (1)
subject tolerance
reported adverse events
Measured: day - 3 through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal HealthStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmology Consultants, Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Ophthalmology Associates, St Louis, Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Joseph Gira, M.D., Ophthalmology Consultants, Ltd.
- Investigators
- Ranjan Maholtra, MD, Principal investigator, Ophthalmology AssociatesJoseph Gira, MD, Principal investigator, Ophthalmology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455233
- Sponsor's protocol ID
- STB-01
- Acronym
- STB-01
- Status last verified
- Dec 2010
- First submitted
- 17 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery
- ClinicalTrials.gov ID
- NCT01455233
- Acronym / sponsor ID
- STB-01 / STB-01
- Conditions
- Corneal Health, Cataract Surgery
- Keywords
- cornea, ocular antibiotic, cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ophthalmology Consultants, Ltd.University, hospital or other
- Collaborators
- Ophthalmology Associates, St Louis, Bausch & Lomb Incorporated
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Oct 2011 (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 demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
Detailed description
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| besivance | Active comparator | Drug: vigamoxocular antibiotic |
| vigamox | Active comparator | Drug: besivanceocular antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery
- Patients who are able to understand and sign an informed consent form that has been approved by an IRB
Key exclusion criteria (17 listed)
- Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism
- Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit
- History of or Fuch's Corneal Endothelial Dystrophy
- Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.
- Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)
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 |
|---|---|---|
| besivanceAlso: besifloxacin ophthalmic suspension 0.6%topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery | Drug | vigamox |
| vigamoxAlso: moxifloxacin hydrochloride ophthalmic solution 0.5%topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery | Drug | besivance |
Primary outcome
corneal health
Time frame: through day 28 post op
Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)
1 secondary outcome
subject tolerance
Time frame: day - 3 through day 28
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 Oct 2011.
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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.
Ranjan Maholtra, MD principal investigator
Ophthalmology Associates
Joseph Gira, MD principal investigator
Ophthalmology Consultants
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing besivance and vigamox in people with Corneal Health and Cataract Surgery, run by Ophthalmology Consultants, Ltd. at 2 sites 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 17 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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 health (time frame: through day 28 post op). 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 Oct 2011.