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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)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01105624
First received: April 15, 2010
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Contact Lens Dry Eye
 Drug: azithromycin ophthalmic solution, 1%
Drug: Visine® for Contacts®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Subject-reported duration of total contact lens daily wear [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Subject-reported rating of overall eye dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Contact Lens-Related Dry Eye Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Tear hyperosmolarity (mOsm) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Habitual low-contrast visual acuity (LCVA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105624

Locations
United States, Ohio
The Ohio State University, College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Merck
Investigators
Study Chair: Reza Haque, MD, PhD Medical Monitor
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mike Schiewe, Associate Director, Inspire
ClinicalTrials.gov Identifier: NCT01105624     History of Changes
Other Study ID Numbers: 041-117, P08644
Study First Received: April 15, 2010
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
 Corneal Diseases
Lacrimal Apparatus Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013