ConjunctivitisPhase 3NCT01028027
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
A Phase 3 study testing Loteprednol and tobramycin and Tobramycin and dexamethasone in people with Conjunctivitis and Keratitis, run by Bausch & Lomb Incorporated at 1 site in Singapore.
Trial summary
This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Keratitis, Blepharitis
- What is being tested?
- Loteprednol and tobramycin and Tobramycin and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2009to Mar 2010
- Phase
- Phase 3
- 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
- Subjects must have a clinical diagnosis of BKC in at least one eye
- Subjects must be willing to discontinue contact lens use for the duration of the study
- Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Who cannot join
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- Subjects who have any uncontrolled systemic disease or debilitating disease.
- Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
- Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
- Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
- Subjects having ocular surgery (including laser surgery) in either eye within the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
- Conditions
- Conjunctivitis, Keratitis, Blepharitis
- Being tested
- Loteprednol and tobramycin, Tobramycin and dexamethasone
- Keywords
- Blepharokeratoconjunctivitis
- Medical subject headings
- Conjunctivitis, Keratitis, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol and tobramycinDrug
Also called Zylet
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Tobramycin and dexamethasoneDrug
Also called Tobradex
Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol and tobramycin | Experimental | Loteprednol etabonate and tobramycin ophthalmic suspension Receives: Drug: Loteprednol and tobramycin |
| Tobramycin and dexamethasone | Active comparator | Tobramycin and dexamethasone ophthalmic suspension Receives: Drug: Tobramycin and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
Measured: Baseline, Day 15
Secondary outcomes (5)
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Measured: Baseline, Day 15
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Measured: Baseline, Day 8
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Measured: Baseline, Day 8
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.
Measured: Baseline, Day 3
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.
Measured: Baseline, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionMar 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConjunctivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Chu, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028027
- Sponsor's protocol ID
- 617
- Status last verified
- Feb 2012
- First submitted
- 8 Dec 2009
- Last updated
- 28 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.
PubMed 22256909
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
- ClinicalTrials.gov ID
- NCT01028027
- Acronym / sponsor ID
- 617
- Conditions
- Conjunctivitis, Keratitis, Blepharitis
- Keywords
- Blepharokeratoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 15 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol and tobramycin | Experimental | Drug: Loteprednol and tobramycinLoteprednol etabonate and tobramycin ophthalmic suspension |
| Tobramycin and dexamethasone | Active comparator | Drug: Tobramycin and dexamethasoneTobramycin and dexamethasone ophthalmic suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinical diagnosis of BKC in at least one eye
- Subjects must be willing to discontinue contact lens use for the duration of the study
- Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Key exclusion criteria (6 listed)
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- Subjects who have any uncontrolled systemic disease or debilitating disease.
- Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
- Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
- Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
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 and tobramycinAlso: ZyletLoteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. | Drug | Loteprednol and tobramycin |
| Tobramycin and dexamethasoneAlso: TobradexTobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. | Drug | Tobramycin and dexamethasone |
Primary outcome
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Time frame: Baseline, Day 15
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
5 secondary outcomes
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
Time frame: Baseline, Day 15
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
Time frame: Baseline, Day 8
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
Time frame: Baseline, Day 8
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
Time frame: Baseline, Day 3
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Time frame: Baseline, Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22256909Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.
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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.
Esther Chu 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 3 study testing Loteprednol and tobramycin and Tobramycin and dexamethasone in people with Conjunctivitis and Keratitis, run by Bausch & Lomb Incorporated at 1 site in Singapore.
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 6 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 28 Feb 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 Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Sep 2011). 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?
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population (time frame: Baseline, Day 15). 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 NCT01028027, 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 28 Feb 2012.