Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optifree RepleniSH Multipurpose Disinfecting Solution | Active Comparator |
| |
| ReNu Multiplus Multipurpose Solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optifree RepleniSH Multipurpose Disinfecting Solution | Drug | lens care system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| 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. | day 7 |
| 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. | baseline |
| 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. | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). | baseline |
| Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). |
Not provided
Inclusion Criteria:
An eligible participant is one who:
Exclusion Criteria:
A person is ineligible if he/she:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Desmond Fonn, M.Optom | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, School of Optometry | Waterloo | Ontario | N2L 3G1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20592230 | Derived | 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. |
Not provided
Not provided
64 participants recruited and screened; 14 withdrawn prior to the group assignment due to loss of interest, relocation and inconvenience.
Participants recruited from local communities in Kitchener-Waterloo, Canada between May 2007 and Feb 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RepleniSH First, Then ReNu | Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period) |
| FG001 | ReNu First, Then RepleniSH | Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout |
|
| ||||||||||||||||||
| First Intervention |
| |||||||||||||||||||
| Washout |
| |||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Group | includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | percent CO2 | baseline |
|
1 year
There were no adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RepleniSH | use RepleniSH for lens care in either first period or second period |
Not provided
Not provided
Sample size completed as anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Craig A Woods | CCLR | 519 888 4567 | 36547 | cawoods@uwaterloo.ca |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ReNu Multiplus Multipurpose Solution | Drug | lens care system |
|
|
| day 7 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Primary | 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. | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | percent CO2 | day 7 |
|
|
|
| Secondary | Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | units on a scale | day 7 |
|
|
|
| Primary | 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. | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | percent CO2 | baseline |
|
|
|
| Primary | 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. | intent to treat analysis including only participants who had completed the study | Posted | Mean | Standard Deviation | percent CO2 | day 7 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | ReNu | use ReNu for lens care in either first period or second period | 0 | 48 | 0 | 48 |
Not provided
Not provided