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

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
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: 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

ClinicalTrials.gov processed this record on October 22, 2014