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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Terminated
Phase 2

Conditions

Blepharitis

Treatments

Drug: Azithromycin ophthalmic solution, 1%
Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01269658
P08636

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

14 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

40 participants in 2 patient groups, including a placebo group

Azithromycin ophthalmic solution, 1%
Experimental group
Treatment:
Drug: Azithromycin ophthalmic solution, 1%
Vehicle
Placebo Comparator group
Treatment:
Drug: Vehicle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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