Ocular Responses to Short and Long-term Lens Wear

Ocular Responses to Acute and Chronic Lens Wear

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: Purevision Lenses with ReNu Multiplus; Device: Purevision Lenses with Optifree RepleniSH

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity.	5 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Trefford Simpson, DipOptom,MSc,PhD, University of Waterloo

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 24, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Eye Diseases
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: P/289/07/B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No