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Trial record 15 of 28 for:    "Conjunctival Disease" | "Azithromycin"

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)

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ClinicalTrials.gov Identifier: NCT01105624
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : September 26, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 15, 2010
First Posted Date  ICMJE April 16, 2010
Last Update Posted Date September 26, 2011
Study Start Date  ICMJE March 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01105624 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Not Provided
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contact Lens Dry Eye
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: azithromycin ophthalmic solution, 1%
    Intervention: Drug: azithromycin ophthalmic solution, 1%
  • Experimental: rewetting drops
    Intervention: Drug: Visine® for Contacts®
Publications * Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01105624
Other Study ID Numbers  ICMJE 041-117
P08644
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mike Schiewe, Associate Director, Inspire
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Reza Haque, MD, PhD Medical Monitor
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP