A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)

Overview

The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

Interventions

  • Drug: azithromycin ophthalmic solution, 1%
    • 1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
  • Drug: Visine® for Contacts®
    • 1-2 drops QID for the treatment period (29 ± 1 day)

Arms, Groups and Cohorts

  • Experimental: azithromycin ophthalmic solution, 1%
  • Experimental: rewetting drops

Clinical Trial Outcome Measures

Primary Measures

  • Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
    • Time Frame: 4 weeks

Secondary Measures

  • Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
    • Time Frame: 2 weeks
  • Subject-reported duration of total contact lens daily wear
    • Time Frame: 4 weeks
  • Subject-reported rating of overall eye dryness
    • Time Frame: 4 weeks
  • Contact Lens-Related Dry Eye Questionnaire
    • Time Frame: 4 weeks
  • Tear hyperosmolarity (mOsm)
    • Time Frame: 4 weeks
  • Habitual low-contrast visual acuity (LCVA)
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Have a history of and current complaint of CLDE. – Use properly fitted daily-wear soft contact lenses. – Able to wear contact lenses for at least 8 hours a day. – If female, are non-pregnant or non-lactating. Exclusion Criteria:

  • Have changed brand of contact lens or care solutions within one month prior to Visit 1. – Use extended (overnight) wear contact lenses. – Have a clinically significant ophthalmic abnormality. – 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 any active ongoing ocular infection or ocular disease. – Have a serious medical condition which could confound study assessments.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Mike Schiewe, Associate Director, Inspire
  • Overall Official(s)
    • Reza Haque, MD, PhD, Study Chair, Medical Monitor

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