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Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

Primary Purpose

Myopia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Soft contact lens
Marketed soft lens multipurpose disinfection regimen
Sponsored by
University of Waterloo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

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

Inclusion Criteria: Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study. Is correctable to a visual acuity of 6/6 or better with their habitual correction. Is willing and able to follow product usage instructions and maintain the visit schedule. Is at least 18 years of age and has full legal capacity to volunteer. Can be successfully fitted with study lens type. Has read, understood and signed an Information Consent Letter. Has a distance contact lens prescription is between -0.50 D and -9.00 D Has astigmatism of ≤ 1.00 D Cyl Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D Has no systemic disease affecting ocular health. Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses. Has clear corneas and no active ocular disease. Has no known ocular or systemic allergies, which could interfere with contact lens wear. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant. Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear. Has not worn extended wear contact lenses in the last 30 days. Has had an oculo-visual examination in the last two years Exclusion Criteria: Has any active ocular disease. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.) Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day) Is using topical ocular prescription or any topical over-the-counter medication. Is actively involved in any other research/clinical study. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days. Has had corneal refractive surgery. Has known sensitivity to any of the study solutions.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Outcomes

Primary Outcome Measures

The primary objective of this study is to compare corneal staining over time in
a group of individuals who wear soft contact lenses on a daily wear basis,
whilst they sequentially use two different contact lens care regimens.

Secondary Outcome Measures

The secondary objective of this study is to compare subjective ocular symptoms
over time in a group of individuals who wear soft contact lenses on a daily wear
basis, whilst they sequentially use two different contact lens care regimens.

Full Information

First Posted
July 5, 2006
Last Updated
December 15, 2015
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00349843
Brief Title
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
Official Title
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Alcon Research

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Soft contact lens
Intervention Type
Drug
Intervention Name(s)
Marketed soft lens multipurpose disinfection regimen
Primary Outcome Measure Information:
Title
The primary objective of this study is to compare corneal staining over time in
Title
a group of individuals who wear soft contact lenses on a daily wear basis,
Title
whilst they sequentially use two different contact lens care regimens.
Secondary Outcome Measure Information:
Title
The secondary objective of this study is to compare subjective ocular symptoms
Title
over time in a group of individuals who wear soft contact lenses on a daily wear
Title
basis, whilst they sequentially use two different contact lens care regimens.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study. Is correctable to a visual acuity of 6/6 or better with their habitual correction. Is willing and able to follow product usage instructions and maintain the visit schedule. Is at least 18 years of age and has full legal capacity to volunteer. Can be successfully fitted with study lens type. Has read, understood and signed an Information Consent Letter. Has a distance contact lens prescription is between -0.50 D and -9.00 D Has astigmatism of ≤ 1.00 D Cyl Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D Has no systemic disease affecting ocular health. Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses. Has clear corneas and no active ocular disease. Has no known ocular or systemic allergies, which could interfere with contact lens wear. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant. Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear. Has not worn extended wear contact lenses in the last 30 days. Has had an oculo-visual examination in the last two years Exclusion Criteria: Has any active ocular disease. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.) Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day) Is using topical ocular prescription or any topical over-the-counter medication. Is actively involved in any other research/clinical study. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days. Has had corneal refractive surgery. Has known sensitivity to any of the study solutions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Woods, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

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