Ocular Responses to Short and Long-term Lens Wear

This study has been completed.
Sponsor:
Information provided by:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00722891
First received: July 24, 2008
Last updated: November 12, 2010
Last verified: November 2010

July 24, 2008
November 12, 2010
July 2008
June 2009   (final data collection date for primary outcome measure)
Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722891 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ocular Responses to Short and Long-term Lens Wear
Ocular Responses to Acute and Chronic Lens Wear

This study will investigate the ocular response to lens wear in 30 subjects.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Ametropia
  • Device: Balafilcon A Lenses with ReNu Multiplus
    Balafilcon A lenses using ReNu Multiplus lens solution for 28 days
  • Device: Balafilcon A Lenses with Optifree RepleniSH
    Balafilcon A lenses using Optifree RepleniSH lens solution for 28 days
  • Active Comparator: Balafilcon A with ReNu
    Balafilcon A Lenses with ReNu Multiplus Solution
    Intervention: Device: Balafilcon A Lenses with ReNu Multiplus
  • Active Comparator: Balafilcon A with RepleniSH
    Balafilcon A Lenses with Optifree RepleniSH Solution
    Intervention: Device: Balafilcon A Lenses with Optifree RepleniSH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is at least 17 years old and has full legal capacity to volunteer;
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;
  • Is a current soft lens wearer and wears contact lenses six or more days/week;
  • Has clear corneas and no active ocular disease.

Exclusion Criteria:

  • Has any clinically significant blepharitis or dry eye;
  • Has undergone corneal refractive surgery;
  • Is aphakic;
  • Has any active ocular disease;
  • Has any systemic disease affecting ocular health;
  • Is using any systemic or topical medications that may affect ocular health;
Both
17 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00722891
P/289/07/B
No
William Reindel, Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Principal Investigator: Trefford Simpson, Dip Optom, MSc, PhD University of Waterloo
Bausch & Lomb Incorporated
November 2010

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