- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754338
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L3G1
- Centre for Contact Lens Research, School of Optometry, University of Waterloo.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Phase1 - Arm 1
|
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Marketed Multipurpose Disinfecting Care System
|
Active Comparator: Phase1 - Arm 2
|
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Marketed Multipurpose Disinfecting Care System
|
Active Comparator: Phase 2 - Arm 1
|
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Marketed Multipurpose Disinfecting Care Systems
|
Active Comparator: Phase 2 - Arm 2
|
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Marketed Multipurpose Disinfecting Care Systems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort
Time Frame: 4 weeks
|
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
|
4 weeks
|
Lens Wettability
Time Frame: 4 weeks
|
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
|
4 weeks
|
Lens Deposits
Time Frame: 4 weeks
|
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dryness
Time Frame: 4 weeks
|
Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
|
4 weeks
|
Subjective Vision
Time Frame: 4 weeks
|
Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
|
4 weeks
|
Corneal Staining
Time Frame: 4 weeks
|
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. |
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Desmond Fonn, MOptom, University of Waterloo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/279/07/L
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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