BlepharitisPhase 2NCT01089608
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
A Phase 2 study testing Azithromycin and Povidone in people with Blepharitis, run by Laboratoires Thea at 1 site in France.
Trial summary
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Azithromycin and Povidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jun 2012
- Phase
- Phase 2
- 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
- -Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye
Who cannot join
- Monophtalmia
- Eyelid dysfunction
- Facial paralysis.
- Severe dry eye syndrome.
- Ocular metaplasia.
- Filamentous keratitis
- Schirmer test < 5 mm.
- Best far corrected visual acuity < 1/10.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Read the detailed description
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.
Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.
Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
- Conditions
- Blepharitis
- Being tested
- Azithromycin, Povidone
- Keywords
- Azyter in patients affected by 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.
AzithromycinDrug
Also called T1225 1.5% - Azyter -
Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
PovidoneDrug
Also called Unifluid
Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
| Study group | Role | What they receive |
|---|---|---|
| Unifluid | Placebo comparator | Eye drops in Single Dose Unit Receives: Drug: Povidone |
| Azithromycin | Experimental | Eye drops Single dose unit Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS - Ranges 0-100 mm)
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
Measured: Baseline and D63 (D63 minus baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 2012
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.
- Other trials for BlepharitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma, VEEDA
- Responsible party
- Sponsor
- Investigators
- Christophe BAUDOUIN, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089608
- Sponsor's protocol ID
- LT1225-PII-06/09
- Other IDs
- 2009-017388-41, 2009
- Status last verified
- Oct 2014
- First submitted
- 17 Mar 2010
- Last updated
- 4 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
- ClinicalTrials.gov ID
- NCT01089608
- Acronym / sponsor ID
- LT1225-PII-06/09
- Conditions
- Blepharitis
- Keywords
- Azyter in patients affected by chronic blepharitis.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma, VEEDA
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 4 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Detailed description
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.
Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.
Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unifluid | Placebo comparator | Drug: PovidoneEye drops in Single Dose Unit |
| Azithromycin | Experimental | Drug: AzithromycinEye drops Single dose unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye
Key exclusion criteria (8 listed)
- Monophtalmia
- Eyelid dysfunction
- Facial paralysis.
- Severe dry eye syndrome.
- Ocular metaplasia.
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 |
|---|---|---|
| AzithromycinAlso: T1225 1.5% - Azyter -Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. | Drug | Azithromycin |
| PovidoneAlso: UnifluidEye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times. | Drug | Unifluid |
Primary outcome
Visual Analogue Scale (VAS - Ranges 0-100 mm)
Time frame: Baseline and D63 (D63 minus baseline)
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Blepharitis
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
RecruitingObservational study
Ocular Dysbiosis in Eyelid Disease
Anterior Blepharitis
Not yet recruitingPhase 4
Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study
Anterior Blepharitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingPhase 2
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Demodex Blepharitis
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.
Christophe BAUDOUIN, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin and Povidone in people with Blepharitis, run by Laboratoires Thea at 1 site in France.
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 1 inclusion and 8 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 4 Nov 2014. 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 France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Nov 2014). 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?
Visual Analogue Scale (VAS - Ranges 0-100 mm) (time frame: Baseline and D63 (D63 minus baseline)). 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 4 Nov 2014.