HealthyPhase 1NCT01120418
Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
A Phase 1 study testing Besifloxacin Ophthalmic Suspension 0.6% in people with Healthy, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Besifloxacin Ophthalmic Suspension 0.6%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes
- Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator
- Must be willing to discontinue contact lens wear for the duration of the study
Who cannot join
- Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study
- History of extended or continuous wear contact lens use other than silicone hydrogels
- History of intraocular surgery
- Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study
- Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days
The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.
- Conditions
- Healthy
- Being tested
- Besifloxacin Ophthalmic Suspension 0.6%
- Keywords
- Endothelial cell density, screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besifloxacin Ophthalmic Suspension 0.6%Drug
Also called ISV-403
administered 3 times a day for 5 days to one eye.
| Study group | Role | What they receive |
|---|---|---|
| Besifloxacin Ophthalmic Suspension 0.6% | Experimental | Topical ocular administration three times daily (TID) for 5 days Receives: Drug: Besifloxacin Ophthalmic Suspension 0.6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell density change between treatment group.
Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.
Measured: Baseline, 5 days
Secondary outcomes (1)
Endothelial cell density change within treatment group
Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.
Measured: Baseline, 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2007
- Primary completionOct 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Trusso, MS, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120418
- Sponsor's protocol ID
- 507
- Status last verified
- Aug 2012
- First submitted
- 7 May 2010
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days
- ClinicalTrials.gov ID
- NCT01120418
- Acronym / sponsor ID
- 507
- Conditions
- Healthy
- Keywords
- Endothelial cell density, screening
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 May 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.
The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Besifloxacin Ophthalmic Suspension 0.6% | Experimental | Drug: Besifloxacin Ophthalmic Suspension 0.6%Topical ocular administration three times daily (TID) for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes
- Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator
- Must be willing to discontinue contact lens wear for the duration of the study
Key exclusion criteria (5 listed)
- Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study
- History of extended or continuous wear contact lens use other than silicone hydrogels
- History of intraocular surgery
- Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study
- Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this 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 |
|---|---|---|
| Besifloxacin Ophthalmic Suspension 0.6%Also: ISV-403administered 3 times a day for 5 days to one eye. | Drug | Besifloxacin Ophthalmic Suspension 0.6% |
Primary outcome
Endothelial cell density change between treatment group.
Time frame: Baseline, 5 days
Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.
1 secondary outcome
Endothelial cell density change within treatment group
Time frame: Baseline, 5 days
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 13 Aug 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.
Laura Trusso, MS study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Besifloxacin Ophthalmic Suspension 0.6% in people with Healthy, 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 5 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 13 Aug 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Endothelial cell density change between treatment group. (time frame: Baseline, 5 days). 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 13 Aug 2012.