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Ocular Responses to Short and Long-term Lens Wear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00722891
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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
Ametropia Device: Purevision Lenses with ReNu Multiplus Device: Purevision Lenses with Optifree RepleniSH Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

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 Name: 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 Name: Balafilcon A




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


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722891


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

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00722891    
Other Study ID Numbers: P/289/07/B
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Keywords provided by Bausch & Lomb Incorporated:
Eye Diseases
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases
Pharmaceutical Solutions