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Corneal and Conjunctival Sensitivity and Staining Study

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Optifree RepleniSH Multipurpose Disinfecting Solution
ReNu Multiplus Multipurpose Solution
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

17 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

An eligible participant is one who:

  • Is between 17-45 years old and has full legal capacity to volunteer.
  • Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
  • Has normal binocular vision (no strabismus, no amblyopia).
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
  • Has astigmatism less than or equal to -1.00DC.
  • Agrees to wear the study lenses on a daily wear basis.
  • Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria:

A person is ineligible if he/she:

  • 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.
  • Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other clinical or research study.
  • Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
  • Has ocular or systemic allergies that could adversely affect contact lens wear.
  • Currently wears lenses on a continuous or extended wear basis.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
  • Is a rigid lens wearer.
  • Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.

Sites / Locations

  • Centre for Contact Lens Research, School of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Optifree RepleniSH Multipurpose Disinfecting Solution

ReNu Multiplus Multipurpose Solution

Arm Description

Outcomes

Primary Outcome Measures

Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

Secondary Outcome Measures

Corneal Staining Grade
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Corneal Staining Grade
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

Full Information

First Posted
March 23, 2007
Last Updated
June 9, 2010
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00455455
Brief Title
Corneal and Conjunctival Sensitivity and Staining Study
Official Title
Corneal and Conjunctival Sensitivity and Staining Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.
Detailed Description
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optifree RepleniSH Multipurpose Disinfecting Solution
Arm Type
Active Comparator
Arm Title
ReNu Multiplus Multipurpose Solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Optifree RepleniSH Multipurpose Disinfecting Solution
Other Intervention Name(s)
lens care system
Intervention Description
lens care system
Intervention Type
Drug
Intervention Name(s)
ReNu Multiplus Multipurpose Solution
Other Intervention Name(s)
lens care system
Intervention Description
lens care system
Primary Outcome Measure Information:
Title
Corneal Sensitivity
Description
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Time Frame
baseline
Title
Corneal Sensitivity
Description
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Time Frame
day 7
Title
Conjunctival Sensitivity
Description
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Time Frame
baseline
Title
Conjunctival Sensitivity
Description
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Time Frame
day 7
Secondary Outcome Measure Information:
Title
Corneal Staining Grade
Description
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Time Frame
baseline
Title
Corneal Staining Grade
Description
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Time Frame
day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: An eligible participant is one who: Is between 17-45 years old and has full legal capacity to volunteer. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers. Is willing and able to follow instructions and maintain the appointment schedule. Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time) Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction. Has normal binocular vision (no strabismus, no amblyopia). Has clear corneas and no active ocular disease. Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS. Has astigmatism less than or equal to -1.00DC. Agrees to wear the study lenses on a daily wear basis. Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study. Exclusion Criteria: A person is ineligible if he/she: 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. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study. Is pregnant or lactating. Is participating in any other clinical or research study. Has a known clinically significant sensitivity to the contact lens care solutions used in the study. Has ocular or systemic allergies that could adversely affect contact lens wear. Currently wears lenses on a continuous or extended wear basis. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable. Is a rigid lens wearer. Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, M.Optom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, School of Optometry
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20592230
Citation
Situ P, Simpson TL, Jones LW, Fonn D. Effects of silicone hydrogel contact lens wear on ocular surface sensitivity to tactile, pneumatic mechanical, and chemical stimulation. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6111-7. doi: 10.1167/iovs.09-4807. Epub 2010 Jun 30.
Results Reference
derived

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Corneal and Conjunctival Sensitivity and Staining Study

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