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Ocular Responses to Short and Long-term Lens Wear

Primary Purpose

Ametropia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Purevision Lenses with ReNu Multiplus

Purevision Lenses with Optifree RepleniSH

About this trial

This is an interventional basic science trial for Ametropia focused on measuring Eye Diseases

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Purevision Lens with ReNu

Purevision Lenses with RepleniSH

Arm Description

Purevision Lenses with ReNu Multiplus Solution

Purevision Lenses with Optifree RepleniSH Solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00722891

First Posted

July 24, 2008

Last Updated

November 24, 2019

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00722891

Brief Title

Ocular Responses to Short and Long-term Lens Wear

Official Title

Ocular Responses to Acute and Chronic Lens Wear

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ametropia

Keywords

Eye Diseases

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Purevision Lens with ReNu

Arm Type

Active Comparator

Arm Description

Purevision Lenses with ReNu Multiplus Solution

Arm Title

Purevision Lenses with RepleniSH

Arm Type

Active Comparator

Arm Description

Purevision Lenses with Optifree RepleniSH Solution

Intervention Type

Device

Intervention Name(s)

Purevision Lenses with ReNu Multiplus

Other Intervention Name(s)

Balafilcon A

Intervention Description

Purevision lenses using ReNu Multiplus lens solution for 28 days

Intervention Type

Device

Intervention Name(s)

Purevision Lenses with Optifree RepleniSH

Other Intervention Name(s)

Balafilcon A

Intervention Description

Purevision lenses using Optifree RepleniSH lens solution for 28 days

Primary Outcome Measure Information:

Title

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

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trefford Simpson, DipOptom,MSc,PhD

Organizational Affiliation

University of Waterloo

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Waterloo

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2L 3G1

Country

Canada

12. IPD Sharing Statement

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Ocular Responses to Short and Long-term Lens Wear

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