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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01105624
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : September 26, 2011
Information provided by:
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Contact Lens Dry Eye Drug: azithromycin ophthalmic solution, 1% Drug: Visine® for Contacts® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: azithromycin ophthalmic solution, 1% 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)
Experimental: rewetting drops Drug: Visine® for Contacts®
1-2 drops QID for the treatment period (29 ± 1 day)

Primary Outcome Measures :
  1. Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint [ Time Frame: 2 weeks ]
  2. Subject-reported duration of total contact lens daily wear [ Time Frame: 4 weeks ]
  3. Subject-reported rating of overall eye dryness [ Time Frame: 4 weeks ]
  4. Contact Lens-Related Dry Eye Questionnaire [ Time Frame: 4 weeks ]
  5. Tear hyperosmolarity (mOsm) [ Time Frame: 4 weeks ]
  6. Habitual low-contrast visual acuity (LCVA) [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01105624

United States, Ohio
The Ohio State University, College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Chair: Reza Haque, MD, PhD Medical Monitor

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mike Schiewe, Associate Director, Inspire Identifier: NCT01105624     History of Changes
Other Study ID Numbers: 041-117
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Bacterial Agents
Anti-Infective Agents