InflammationPhase 4NCT00532961
Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex
A Phase 4 study testing Loteprednol etabonate 0.5% and tobramycin 0.3% and Dexamethasone 0.1% and tobramycin 0.3% in people with Inflammation, run by Bausch & Lomb Incorporated.
Trial summary
Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Loteprednol etabonate 0.5% and tobramycin 0.3% and Dexamethasone 0.1% and tobramycin 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jun 2005
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in good general health based on investigator judgment
- able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
- possessing a best corrected visual acuity of at least 20/40 in each eye
- for females, using reliable contraception and a negative urine pregnancy test prior to study entry
Who cannot join
- contact lenses worn within 30 days prior to enrollment or during study period
- known hypersensitivity to study medication or any component
- presence of significant ocular or systemic disease that might interfere with the interpretation of the results
- a need for administration of chronic topical ocular or systemic medications of any kind during the study.
- participation in an opthalmic drug or device research study within 30 days prior to entry
About this study
Official title: A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers
Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.
- Conditions
- Inflammation
- Being tested
- Loteprednol etabonate 0.5% and tobramycin 0.3%, Dexamethasone 0.1% and tobramycin 0.3%
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol etabonate 0.5% and tobramycin 0.3%Drug
Also called Zylet
ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
Dexamethasone 0.1% and tobramycin 0.3%Drug
Also called TobraDex
ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Zylet | Experimental | Zylet (loteprednol etabonate and tobramycin) Receives: Drug: Loteprednol etabonate 0.5% and tobramycin 0.3% |
| Tobradex | Active comparator | TobraDex (dexamethasone and tobramycin) Receives: Drug: Dexamethasone 0.1% and tobramycin 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular comfort/tolerability
Measured: Day 1, 3, 8, 15, 22 and 29
Intraocular pressure measurements
Measured: Day 1, 3, 8,15, 22 and 29
Secondary outcomes (1)
Assessment of safety
Measured: Througout 28-day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startFeb 2005
- Primary completionApr 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy L Comstock, DO, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532961
- Sponsor's protocol ID
- 372
- Status last verified
- Dec 2011
- First submitted
- 20 Sep 2007
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.
PubMed 18577309
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00532961
- Acronym / sponsor ID
- 372
- Conditions
- Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 21 Sep 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.
Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zylet | Experimental | Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%Zylet (loteprednol etabonate and tobramycin) |
| Tobradex | Active comparator | Drug: Dexamethasone 0.1% and tobramycin 0.3%TobraDex (dexamethasone and tobramycin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- in good general health based on investigator judgment
- able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
- possessing a best corrected visual acuity of at least 20/40 in each eye
- for females, using reliable contraception and a negative urine pregnancy test prior to study entry
Key exclusion criteria (5 listed)
- contact lenses worn within 30 days prior to enrollment or during study period
- known hypersensitivity to study medication or any component
- presence of significant ocular or systemic disease that might interfere with the interpretation of the results
- a need for administration of chronic topical ocular or systemic medications of any kind during the study.
- participation in an opthalmic drug or device research study within 30 days prior to entry
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 |
|---|---|---|
| Loteprednol etabonate 0.5% and tobramycin 0.3%Also: Zyletophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days | Drug | Zylet |
| Dexamethasone 0.1% and tobramycin 0.3%Also: TobraDexophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days. | Drug | Tobradex |
Primary outcome
Ocular comfort/tolerability
Time frame: Day 1, 3, 8, 15, 22 and 29
Intraocular pressure measurements
Time frame: Day 1, 3, 8,15, 22 and 29
1 secondary outcome
Assessment of safety
Time frame: Througout 28-day study
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 8 Dec 2011.
- Derived from this study: PubMed 18577309Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.
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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.
Timothy L Comstock, DO study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loteprednol etabonate 0.5% and tobramycin 0.3% and Dexamethasone 0.1% and tobramycin 0.3% in people with Inflammation, run by Bausch & Lomb Incorporated.
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 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 8 Dec 2011. 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?
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?
Ocular comfort/tolerability (time frame: Day 1, 3, 8, 15, 22 and 29). The study lists 2 primary outcomes in all. 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 NCT00532961, which also lists 1 linked publication.
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 8 Dec 2011.