BlepharitisPhase 2NCT01269658
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
A Phase 2 study testing Azithromycin ophthalmic solution, 1% in people with Blepharitis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Blepharitis
- What is being tested?
- Azithromycin ophthalmic solution, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2011
- Phase
- Phase 2
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a current diagnosis of blepharitis
- Have a best corrected visual acuity (BCVA), using corrective lenses if
- necessary, in both eyes of at least +0.7
- If female, are non-pregnant or non-lactating
Who cannot join
- Have a concurrent acute hordeolum (stye) or chalazion
- Have inflammation of the ocular surface
- Have used artificial tears within 48 hours prior to Visit 1 or anticipate
- using during the study
- Have had ocular surgery in the past 90 days or will require it during the
- study
Show all 14Show fewer
- Unable to withhold the use of contact lenses during the study
- Have a known hypersensitivity to azithromycin, erythromycin, any other
- macrolide antibiotic, or any of the other ingredients in the study
- medication
- Have been diagnosed with ongoing glaucoma
- Unable to withhold the use of ocular cosmetic products within 48 hours
- prior to Visit 1 and throughout the study
- Have a serious medical condition which could confound study assessments
About this study
Official title: A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis
The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.
- Conditions
- Blepharitis
- Being tested
- Azithromycin ophthalmic solution, 1%, Vehicle
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin ophthalmic solution, 1%Drug
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
VehicleDrug
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin ophthalmic solution, 1% | Experimental | Not described Receives: Drug: Azithromycin ophthalmic solution, 1% |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of clinical signs of blepharitis
Measured: Day 28
Secondary outcomes (4)
Time to first clinical resolution
Measured: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis
Measured: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from end of dosing for clinical signs of blepharitis
Measured: Days 42, 56, 70, and 84
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Measured: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Johnson, MBChB, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269658
- Sponsor's protocol ID
- P08636
- Other IDs
- P08636
- Status last verified
- Oct 2013
- First submitted
- 21 Dec 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis
- ClinicalTrials.gov ID
- NCT01269658
- Acronym / sponsor ID
- P08636
- Conditions
- Blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Jan 2011 (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 compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.
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 |
|---|---|---|
| Azithromycin ophthalmic solution, 1% | Experimental | Drug: Azithromycin ophthalmic solution, 1% |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have a current diagnosis of blepharitis
- Have a best corrected visual acuity (BCVA), using corrective lenses if
- necessary, in both eyes of at least +0.7
- If female, are non-pregnant or non-lactating
Key exclusion criteria (14 listed)
- Have a concurrent acute hordeolum (stye) or chalazion
- Have inflammation of the ocular surface
- Have used artificial tears within 48 hours prior to Visit 1 or anticipate
- using during the study
- Have had ocular surgery in the past 90 days or will require it during the
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 |
|---|---|---|
| Azithromycin ophthalmic solution, 1%1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total) | Drug | Azithromycin ophthalmic solution, 1% |
| Vehicle1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total) | Drug | Vehicle |
Primary outcome
Resolution of clinical signs of blepharitis
Time frame: Day 28
4 secondary outcomes
Time to first clinical resolution
Time frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis
Time frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from end of dosing for clinical signs of blepharitis
Time frame: Days 42, 56, 70, and 84
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Time frame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Charles Johnson, MBChB study chair
Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin ophthalmic solution, 1% in people with Blepharitis, run by Merck Sharp & Dohme LLC.
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 14 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: stopped early, as of the sponsor's last update on 21 Nov 2013. 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. 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?
The study was stopped early. Results are not available in the source record.
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?
Resolution of clinical signs of blepharitis (time frame: Day 28). 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 21 Nov 2013.