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
  Purpose

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


Condition Intervention Phase
Ametropia
Device: Balafilcon A Lenses with ReNu Multiplus
Device: Balafilcon A Lenses with Optifree RepleniSH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Ocular Responses to Acute and Chronic Lens Wear

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balafilcon A with ReNu
Balafilcon A Lenses with ReNu Multiplus Solution
Device: Balafilcon A Lenses with ReNu Multiplus
Balafilcon A lenses using ReNu Multiplus lens solution for 28 days
Active Comparator: Balafilcon A with RepleniSH
Balafilcon A Lenses with Optifree RepleniSH Solution
Device: Balafilcon A Lenses with Optifree RepleniSH
Balafilcon A lenses using Optifree RepleniSH lens solution for 28 days

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722891

Locations
Canada, Ontario
University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Trefford Simpson, Dip Optom, MSc, PhD University of Waterloo
  More Information

No publications provided

Responsible Party: William Reindel, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00722891     History of Changes
Other Study ID Numbers: P/289/07/B
Study First Received: July 24, 2008
Last Updated: November 12, 2010
Health Authority: Canada: Health Canada

Keywords provided by Bausch & Lomb Incorporated:
Eye Diseases

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014