NCT00722891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

July 24, 2008

Last Update Submit

November 24, 2019

Conditions

Ametropia

Keywords

Eye Diseases

Outcome Measures

Primary Outcomes (1)

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

    5 months

Study Arms (2)

Purevision Lens with ReNu

ACTIVE COMPARATOR

Purevision Lenses with ReNu Multiplus Solution

Device: Purevision Lenses with ReNu Multiplus

Purevision Lenses with RepleniSH

ACTIVE COMPARATOR

Purevision Lenses with Optifree RepleniSH Solution

Device: Purevision Lenses with Optifree RepleniSH

Interventions

Purevision Lenses with ReNu MultiplusDEVICE

Purevision lenses using ReNu Multiplus lens solution for 28 days

Also known as: Balafilcon A
Purevision Lens with ReNu
Purevision Lenses with Optifree RepleniSHDEVICE

Purevision lenses using Optifree RepleniSH lens solution for 28 days

Also known as: Balafilcon A
Purevision Lenses with RepleniSH

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Refractive ErrorsEye Diseases

Study Officials

  • Trefford Simpson, DipOptom,MSc,PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

CA(1)