A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

NCT01269658 | Terminated Phase 2

• 1 other identifier: P08636
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (1)

• Resolution of clinical signs of blepharitis

  Day 28

Secondary Outcomes (4)

• Time to first clinical resolution

  Days 7, 14, 21, 28, 42, 56, 70, and 84

• Mean and change from baseline for clinical signs of blepharitis

  Days 7, 14, 21, 28, 42, 56, 70, and 84

• Mean and change from end of dosing for clinical signs of blepharitis

  Days 42, 56, 70, and 84

• Response to the Blepharitis Symptoms Questionnaire (BSQ)

  Days 1, 7, 14, 21, 28, 42, 56, 70, and 84

Study Arms (2)

Azithromycin ophthalmic solution, 1%

EXPERIMENTAL

Drug: Azithromycin ophthalmic solution, 1%

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

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)

Azithromycin ophthalmic solution, 1%

Vehicle 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)

Vehicle

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a current diagnosis of blepharitis
• Have a best corrected visual acuity (BCVA), using corrective lenses if
• necessary, in both eyes of at least +0.7
• If female, are non-pregnant or non-lactating

You may not qualify if:

• Have a concurrent acute hordeolum (stye) or chalazion
• Have inflammation of the ocular surface
• Have used artificial tears within 48 hours prior to Visit 1 or anticipate
• using during the study
• Have had ocular surgery in the past 90 days or will require it during the
• study
• Unable to withhold the use of contact lenses during the study
• Have a known hypersensitivity to azithromycin, erythromycin, any other
• macrolide antibiotic, or any of the other ingredients in the study
• medication
• Have been diagnosed with ongoing glaucoma
• Unable to withhold the use of ocular cosmetic products within 48 hours
• prior to Visit 1 and throughout the study
• Have a serious medical condition which could confound study assessments

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Charles Johnson, MBChB

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 21, 2013

Record last verified: 2013-10