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Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Primary Purpose

Ametropia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alcon Opti-Free® RepleniSH® with Supraclens®
Alcon Opti-Free® RepleniSH®
B&L ReNu MultiPlus™
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ametropia focused on measuring comfort, wetability, protein deposit, lipid deposit

Eligibility Criteria

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

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Has read, understood and signed an information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.
  • Is a current soft lens wearer, replacing their lenses every two weeks to one month.
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
  • Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

  • Has any signs or symptoms of dry eye.
  • Has any clinically significant blepharitis.
  • 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • Currently wears daily disposable lenses.
  • Currently wears lenses on an extended wear basis.

Sites / Locations

  • Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Phase1 - Arm 1

Phase1 - Arm 2

Phase 2 - Arm 1

Phase 2 - Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Comfort
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Lens Wettability
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Lens Deposits
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).

Secondary Outcome Measures

Dryness
Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Subjective Vision
Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Corneal Staining
Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.

Full Information

First Posted
September 17, 2008
Last Updated
September 21, 2023
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00754338
Brief Title
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Official Title
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 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 purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.
Detailed Description
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
Keywords
comfort, wetability, protein deposit, lipid deposit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase1 - Arm 1
Arm Type
Active Comparator
Arm Title
Phase1 - Arm 2
Arm Type
Active Comparator
Arm Title
Phase 2 - Arm 1
Arm Type
Active Comparator
Arm Title
Phase 2 - Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Alcon Opti-Free® RepleniSH® with Supraclens®
Intervention Description
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Intervention Type
Drug
Intervention Name(s)
Alcon Opti-Free® RepleniSH®
Intervention Description
Marketed Multipurpose Disinfecting Care System
Intervention Type
Drug
Intervention Name(s)
B&L ReNu MultiPlus™
Intervention Description
Marketed Multipurpose Disinfecting Care Systems
Primary Outcome Measure Information:
Title
Comfort
Description
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Time Frame
4 weeks
Title
Lens Wettability
Description
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Time Frame
4 weeks
Title
Lens Deposits
Description
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dryness
Description
Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Time Frame
4 weeks
Title
Subjective Vision
Description
Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Time Frame
4 weeks
Title
Corneal Staining
Description
Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer. Has read, understood and signed an information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. Has clear corneas and no active ocular disease. Has had an ocular examination in the last two years. Is a current soft lens wearer, replacing their lenses every two weeks to one month. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens. Has astigmatism less than or equal to -1.00 DC. Exclusion Criteria: Has any signs or symptoms of dry eye. Has any clinically significant blepharitis. 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study. Is pregnant or lactating. Is participating in any other type of clinical or research study. Currently wears daily disposable lenses. Currently wears lenses on an extended wear basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom
Organizational Affiliation
University of Waterloo
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for Contact Lens Research, School of Optometry, University of Waterloo.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada

12. IPD Sharing Statement

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Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

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