Posterior BlepharoconjunctivitisPhase 2NCT01220258
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
A Phase 2 study testing Azithromycin ophthalmic solution, 1% in people with Posterior Blepharoconjunctivitis, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posterior Blepharoconjunctivitis
- What is being tested?
- Azithromycin ophthalmic solution, 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a current diagnosis of posterior blepharoconjunctivitis in both eyes
- (except for healthy volunteers)
- Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
- If female, are non-pregnant or non-lactating
Who cannot join
- Have anterior blepharitis
- Have lid structural abnormalities
- Have had penetrating intraocular surgery in the past 90 days or require
- penetrating intraocular surgery during the study
- Unable to withhold the use of contact lenses within 3 days prior to Visit 1
- during the study
- Have been diagnosed with ongoing glaucoma
- Have a serious medical condition which could confound study assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.
- Conditions
- Posterior Blepharoconjunctivitis
- Being tested
- Azithromycin ophthalmic solution, 1%
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)
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin ophthalmic solution, 1% | Experimental | Not described Receives: Drug: Azithromycin ophthalmic solution, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of investigator-rated scores for eyelid margin erythema
Measured: Week 4
Secondary outcomes (2)
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
Measured: Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
Measured: Weeks 2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior BlepharoconjunctivitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220258
- Sponsor's protocol ID
- P08641
- Other IDs
- 041-118
- Status last verified
- Dec 2013
- First submitted
- 12 Oct 2010
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks
- ClinicalTrials.gov ID
- NCT01220258
- Acronym / sponsor ID
- P08641
- Conditions
- Posterior Blepharoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Oct 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.
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin ophthalmic solution, 1% | Experimental | Drug: Azithromycin ophthalmic solution, 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a current diagnosis of posterior blepharoconjunctivitis in both eyes
- (except for healthy volunteers)
- Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
- If female, are non-pregnant or non-lactating
Key exclusion criteria (8 listed)
- Have anterior blepharitis
- Have lid structural abnormalities
- Have had penetrating intraocular surgery in the past 90 days or require
- penetrating intraocular surgery during the study
- Unable to withhold the use of contact lenses within 3 days prior to Visit 1
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% |
Primary outcome
Change from baseline of investigator-rated scores for eyelid margin erythema
Time frame: Week 4
2 secondary outcomes
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
Time frame: Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
Time frame: Weeks 2, 4, 6, 8
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 16 Dec 2013.
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
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 ophthalmic solution, 1% in people with Posterior Blepharoconjunctivitis, run by Merck Sharp & Dohme LLC 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 4 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: stopped early, as of the sponsor's last update on 16 Dec 2013. 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 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?
Change from baseline of investigator-rated scores for eyelid margin erythema (time frame: Week 4). 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 16 Dec 2013.