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Ocular Responses to Short and Long-term Lens Wear

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00722891
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
14
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.

Condition or Disease Intervention/Treatment Phase
  • Device: Purevision Lenses with ReNu Multiplus
  • Device: Purevision Lenses with Optifree RepleniSH
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Ocular Responses to Acute and Chronic Lens Wear
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Purevision Lens with ReNu

Purevision Lenses with ReNu Multiplus Solution

Device: Purevision Lenses with ReNu Multiplus
Purevision lenses using ReNu Multiplus lens solution for 28 days
Other Names:
  • Balafilcon A

    		•
    Active Comparator: Purevision Lenses with RepleniSH

    Purevision Lenses with Optifree RepleniSH Solution

    Device: Purevision Lenses with Optifree RepleniSH
    Purevision lenses using Optifree RepleniSH lens solution for 28 days
    Other Names:
  • Balafilcon A

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity. [5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Waterloo Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Principal Investigator: Trefford Simpson, DipOptom,MSc,PhD, University of Waterloo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00722891
    Other Study ID Numbers:
    • P/289/07/B
    First Posted:
    Jul 28, 2008
    Last Update Posted:
    Nov 26, 2019
    Last Verified:
    Nov 1, 2019
    Keywords provided by Bausch & Lomb Incorporated
    Eye Diseases
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Nov 26, 2019