BlepharitisPhase 3NCT01102244
A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
A Phase 3 study testing Tobradex ST and Azasite in people with Blepharitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Tobradex ST and Azasite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- Phase
- Phase 3
- 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
- Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye
- Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.
Who cannot join
- Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial
- Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study
- Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis
- Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study
- Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days
- Have used any topical ocular or systemic antibiotics within 7 days of enrollment. Stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. Dose must continue unchanged for duration of study
- Have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. Stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. Dose must continue unchanged for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.
- Conditions
- Blepharitis
- Being tested
- Tobradex ST, Azasite
- Keywords
- blepharitis, moderate to severe chronic blepharitis
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobradex STDrug
tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
AzasiteDrug
azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days
| Study group | Role | What they receive |
|---|---|---|
| Tobradex ST | Experimental | tobramycin 0.3%, dexamethasone 0.05% Receives: Drug: Tobradex ST |
| Azasite | Active comparator | azithromycin 1% Receives: Drug: Azasite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global sign and symptom score for blepharitis
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
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 BlepharitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102244
- Sponsor's protocol ID
- SMA-09-35
- Status last verified
- Jan 2011
- First submitted
- 9 Apr 2010
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Torkildsen GL, Cockrum P, Meier E, Hammonds WM, Silverstein B, Silverstein S. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. Curr Med Res Opin. 2011 Jan;27(1):171-8. doi: 10.1185/03007995.2010.539603. Epub 2010 Dec 7.
PubMed 21138337
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
- ClinicalTrials.gov ID
- NCT01102244
- Acronym / sponsor ID
- SMA-09-35
- Conditions
- Blepharitis
- Keywords
- blepharitis, moderate to severe chronic blepharitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 13 Apr 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 purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobradex ST | Experimental | Drug: Tobradex STtobramycin 0.3%, dexamethasone 0.05% |
| Azasite | Active comparator | Drug: Azasiteazithromycin 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye
- Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.
Key exclusion criteria (7 listed)
- Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial
- Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study
- Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis
- Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study
- Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days
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 |
|---|---|---|
| Tobradex STtobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days | Drug | Tobradex ST |
| Azasiteazithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days | Drug | Azasite |
Primary outcome
Global sign and symptom score for blepharitis
Time frame: Day 15
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 11 Jun 2012.
- Derived from this study: PubMed 21138337Torkildsen GL, Cockrum P, Meier E, Hammonds WM, Silverstein B, Silverstein S. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. Curr Med Res Opin. 2011 Jan;27(1):171-8. doi: 10.1185/03007995.2010.539603. Epub 2010 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tobradex ST and Azasite in people with Blepharitis, run by Alcon Research 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 2 inclusion and 7 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 11 Jun 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 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?
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?
Global sign and symptom score for blepharitis (time frame: 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 NCT01102244, 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 11 Jun 2012.