BlepharitisPhase 2NCT00892970
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period
A Phase 2 study testing Azithromycin ophthalmic solution, 1% in people with Blepharitis, run by Merck Sharp & Dohme LLC at 33 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 two-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
- 313 participants
- Where
- 33 sitesUnited States
- Study dates
- Apr 2009to Jan 2010
- 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
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Sall Medical Research Center
Artesia, California, 90701
Eye Clinic of Austin
Austin, Texas, 78731
Milton Hom, OD
Azusa, California, 91702
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, 21287
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Florida Eye Microsurgical Institute
Boynton Beach, Florida, 33426
Mundorf Eye Center
Charlotte, North Carolina, 28204
Abrams Eye Center
Cleveland, Ohio, 44115
Eye Centers of Florida
Fort Myers, Florida, 33901
NorthShore University HealthSystems
Glenview, Illinois, 60025
TLC Laser Eye Center
Greensboro, North Carolina, 27410
Eye Center - A Medical and Surgical Group
Hamden, Connecticut, 06518
Cornerstone Eye Care
High Point, North Carolina, 27262
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Indiana University School of Medicine, Ophthalmology Dept.
Indianapolis, Indiana, 46202
Eye Physicians and Surgeons, LLP
Iowa City, Iowa, 52245
Koffler Vision Group
Lexington, Kentucky, 40509
Jones Eye Institute
Little Rock, Arkansas, 72205
The Jules Stein Eye Institute UCLA Laser Refractive Center
Los Angeles, California, 90095
See Clearly Vision Group
McLean, Virginia, 22101
Minnesota Eye Consultants
Minneapolis, Minnesota, 55404
North Valley Eye Medical Group
Mission Hills, California, 91345
McCabe Vision Center
Murfreesboro, Tennessee, 37129
David Wirta, MD, Inc.
Newport Beach, California, 92663
Virginia Eye Consultants
Norfolk, Virginia, 23502
North Bay Eye Associates
Petaluma, California, 94954
West Coast Eye Care
San Diego, California, 92115-1754
Ophthalmology Associates
St Louis, Missouri, 63131
Ophthalmology Consultants
St Louis, Missouri, 63131
Wolstan Eye Associates
Torrence, California, 90505
South Shore Eye Care
Wantagh, New York, 11793
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
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 two-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 12 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 12 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: Two weeks
Secondary outcomes (1)
Signs and symptoms of Blepharitis
Measured: One week, two weeks, three weeks, four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Reza Haque, MD, PhD, Study chair, Medical Monitor, Inspire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892970
- Sponsor's protocol ID
- 044-101
- Other IDs
- P08639
- Status last verified
- Sep 2011
- First submitted
- 1 May 2009
- Last updated
- 26 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. 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 Two-Week Treatment Period
- ClinicalTrials.gov ID
- NCT00892970
- Acronym / sponsor ID
- 044-101
- Conditions
- Blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 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 two-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 12 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 12 days | Drug | 2 |
Primary outcome
Eyelid margin erythema
Time frame: Two weeks
1 secondary outcome
Signs and symptoms of Blepharitis
Time frame: One week, two weeks, three weeks, four 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 26 Sep 2011.
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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
33 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 33 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 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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: Two 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 26 Sep 2011.