A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01220258
First received: October 12, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Posterior Blepharoconjunctivitis
Drug: Azithromycin ophthalmic solution, 1%
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline of investigator-rated scores for eyelid margin erythema [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of investigator-rated scores of blepharoconjunctivitis signs [ Time Frame: Weeks 2, 4, 6, 8 ] [ Designated as safety issue: No ]
  • Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms [ Time Frame: Weeks 2, 4, 6, 8 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin ophthalmic solution, 1% Drug: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220258

Locations
United States, Texas
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Reza Haque, MD, PhD Medical Monitor
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01220258     History of Changes
Other Study ID Numbers: P08641, 041-118
Study First Received: October 12, 2010
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Azithromycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 21, 2014