BlepharitisPhase 2NCT00894530
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
A Phase 2 study testing Azithromycin ophthalmic solution, 1% in people with Blepharitis, run by Merck Sharp & Dohme LLC at 26 sites in United States.
Trial summary
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period. 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 ophthalmic solution, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 26 sitesUnited States
- Study dates
- May 2009to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have best corrected visual acuity in both eyes of at least +0.7 or better
- If female, are non-pregnant or non-lactating
- Have a current diagnosis of blepharitis in one or both eyes
Who cannot join
- Have lid structural abnormalities
- Have suspected ocular fungal or viral infection
- Have practiced warm compress therapy within 14 days prior to Visit 2
- Unable to withhold the use of contact lenses during the treatment or follow-up periods
- Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
- Have had penetrating intraocular surgery within 90 days prior to Visit 2
- Have had ocular surface surgery within the past year prior to Visit 2
- Have a serious medical condition which could confound study assessments
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Sall Research Medical Center, Inc.
Artesia, California, 90701
Sall Research Medical Center
Artesia, California, 90701
Eastern Maine Medical Center
Bangor, Maine, 04401
Wohl Eye Center
Bloomingdale, Illinois, 60108
Hernando Eye Institute
Brooksville, Florida, 34613
Ohio State University - College of Optometry
Columbus, Ohio, 43210
Columbus Ophthalmology Associates
Columbus, Ohio, 43213
Park Ophthalmology
Durham, North Carolina, 27713
McDonald Eye Associates
Fayetteville, Arkansas, 72703
United Medical Research Company
Inglewood, California, 90301
Taustine Eye Center
Louisville, Kentucky, 40217
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Total Eye Care, PA
Memphis, Tennessee, 38119
Center for Excellence in Eye Care
Miami, Florida, 33176
North Valley Eye Medical Group
Mission Hills, California, 91345
Coastal Vision Medical Group
Newport Beach, California, 92660
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Eye Clinics of South Texas
San Antonio, Texas, 78209
West Coast Eye Care
San Diego, California, 92115-1754
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
David M. Ringel, DO, PA
Sewell, New Jersey, 08080
Ophthalmology Associates
St Louis, Missouri, 63131
Thomas John Vision Institute
Tinley Park, Illinois, 60477
Comprehensive Eye Care Ltd
Washington, Missouri, 63090
Grene Vision Group
Wichita, Kansas, 67208
Brar-Parekh Eye Associates
Woodland Park, New Jersey, 07424
About this study
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
- Conditions
- Blepharitis
- Being tested
- Azithromycin ophthalmic solution, 1%, Placebo
- 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
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
PlaceboDrug
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Azithromycin ophthalmic solution, 1% |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid margin erythema
Measured: Four weeks
Secondary outcomes (1)
Signs and symptoms of Blepharitis
Measured: One week, two weeks, three weeks, four weeks, six weeks, eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reza Haque, MD,PhD, Study chair, Medical Monitor, Inspire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894530
- Sponsor's protocol ID
- P08638
- Other IDs
- 044-102
- Status last verified
- Oct 2013
- First submitted
- 5 May 2009
- 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
- The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
- ClinicalTrials.gov ID
- NCT00894530
- Acronym / sponsor ID
- P08638
- Conditions
- Blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 May 2009 (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 objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
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 |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin ophthalmic solution, 1% |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have best corrected visual acuity in both eyes of at least +0.7 or better
- If female, are non-pregnant or non-lactating
- Have a current diagnosis of blepharitis in one or both eyes
Key exclusion criteria (8 listed)
- Have lid structural abnormalities
- Have suspected ocular fungal or viral infection
- Have practiced warm compress therapy within 14 days prior to Visit 2
- Unable to withhold the use of contact lenses during the treatment or follow-up periods
- Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
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%One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days | Drug | 1 |
| PlaceboOne drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days | Drug | 2 |
Primary outcome
Eyelid margin erythema
Time frame: Four weeks
1 secondary outcome
Signs and symptoms of Blepharitis
Time frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks
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 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.
Reza Haque, MD,PhD study chair
Medical Monitor, Inspire
26 sites 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 ophthalmic solution, 1% in people with Blepharitis, run by Merck Sharp & Dohme LLC at 26 sites 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 3 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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. 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 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?
Eyelid margin erythema (time frame: Four weeks). 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.