Myopia
Conditions
Brief summary
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Detailed description
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings
Interventions
DRUGClearCare
contact lens care system
DRUGOptifree Replenish
contact lens care system
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: 1. Is at least 17 years of age and has full legal capacity to volunteer. 2. Has read, understood and signed an information consent letter. 3. Is willing and able to follow instructions and maintain the appointment schedule. 4. Is presently using either bi-weekly or monthly replacement lenses. 5. Has symptoms of ocular dryness as determined by specific pre-screening criteria. 6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. 7. Has clear corneas and no active ocular disease. 8. Has had an ocular examination in the last two years.
Exclusion criteria
A person will be excluded from the study if he/she: 1. Is an asymptomatic lens wearer. 2. Is a daily disposable contact lens wearer. 3. Is a current extended wear contact lens wearer. 4. Currently uses one of the study lens care regimens. 5. Has any clinically significant blepharitis. 6. Has undergone corneal refractive surgery. 7. Is aphakic. 8. Has any active ocular disease. 9. Has any systemic disease affecting ocular health. 10. Is using any systemic or topical medications that may affect ocular health. 11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 12. Is participating in any other type of clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Visual Acuity | 2 weeks | High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step. |
| Low Contrast Visual Acuity | 2 weeks | Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step. |
| In-vivo Wettability | 2 weeks | Pre-lens non-invasive tear breakup time |
| Subjective Comfort Rating | 2 weeks | Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort. |
Countries
Canada
Participant flow
Recruitment details
Study completion date is August 2008
Pre-assignment details
Washout for 2 to 3 days following screening (wear spectacles only).
Participants by arm
| Arm | Count |
|---|---|
| ClearCare First, Then Optifree Replenish In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first. | 15 |
| Optifree Replenish First, Then ClearCare In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Optifree Replenish First, Then ClearCare | ClearCare First, Then Optifree Replenish | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 29 Participants |
| Age Continuous | 24.1 years STANDARD_DEVIATION 4.4 | 24.4 years STANDARD_DEVIATION 5.9 | 24.3 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment Canada | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
High Contrast Visual Acuity
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ClearCare First, Then Optifree Replenish | High Contrast Visual Acuity | -0.04 logMAR | Standard Deviation 0.06 |
| Optifree Replenish First, Then ClearCare | High Contrast Visual Acuity | -0.04 logMAR | Standard Deviation 0.06 |
Primary
In-vivo Wettability
Pre-lens non-invasive tear breakup time
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ClearCare First, Then Optifree Replenish | In-vivo Wettability | 7.06 Seconds |
| Optifree Replenish First, Then ClearCare | In-vivo Wettability | 6.54 Seconds |
Primary
Low Contrast Visual Acuity
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Time frame: 2 weeks
Population: Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ClearCare First, Then Optifree Replenish | Low Contrast Visual Acuity | 0.26 logMAR | Standard Deviation 0.07 |
| Optifree Replenish First, Then ClearCare | Low Contrast Visual Acuity | 0.25 logMAR | Standard Deviation 0.08 |
Primary
Subjective Comfort Rating
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ClearCare First, Then Optifree Replenish | Subjective Comfort Rating | 82.5 Units on a scale |
| Optifree Replenish First, Then ClearCare | Subjective Comfort Rating | 81.3 Units on a scale |