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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01105624
First received: April 15, 2010
Last updated: September 20, 2011
Last verified: September 2011
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Study Chair: Reza Haque, MD, PhD Medical Monitor
  More Information

No publications provided by Merck Sharp & Dohme Corp.

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
Ophthalmic Solutions
Pharmaceutical Solutions
Azithromycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 14, 2014