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NCT01220258
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
Phase 2 trial testing Azithromycin ophthalmic solution, 1% in Posterior Blepharoconjunctivitis in 29 participants. Terminated before completion.
1 August 2011
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 1 November 2010 |
| Primary completion | 1 August 2011 |
| Estimated completion | 1 August 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azithromycin ophthalmic solution, 1% — full drug profile →
Conditions studied
- Posterior Blepharoconjunctivitis — all drugs for Posterior Blepharoconjunctivitis →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
18 and older, any sex, with Posterior Blepharoconjunctivitis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline of investigator-rated scores for eyelid margin erythema
Time frame: Week 4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01220258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01220258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 13 December 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01220258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing