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Completed

NCT Number: NCT01014078

A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sall Research Medical Center, Inc., Artesia, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a current diagnosis of dry eye in one or both eyes
  • Moderate to severe degree of meibomian gland plugging
  • Have best corrected visual acuity 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 suspected ocular fungal or viral infection
  • Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
  • Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.
  • 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 a history of post vitreous detachment.
  • Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).
  • Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.
  • Have a congenitally absent meibomian gland or lacrimal gland.
  • Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
  • Have a serious medical condition which would confound study assessments.
  • Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.

Treatment and study plan

azithromycin ophthalmic solution, 1%

Drug

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Placebo

Drug

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Primary outcomes

  1. Tear Break-Up Time (TBUT)

    Time frame: 4 weeks

Secondary outcomes

  1. Corneal Staining

    Time frame: 4 weeks

  2. Tear Volume

    Time frame: 4 weeks

  3. Meibomian gland plugging

    Time frame: 4 weeks

  4. Subject-rated scores of dry eye symptoms

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2009
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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