Astigmatism, Myopia
Conditions
Brief summary
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
Interventions
DEVICESofLens DD Toric
daily disposable wear contact lens for 2 weeks
DEVICECiba Vision Focus Dailies Toric Contact Lens
daily disposable wear contact lens for 2 weeks
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater * Visual acuity (VA) correctable to 0.3 logMar or better (driving vision) * Clear central cornea
Exclusion criteria
* Systemic disease affecting ocular health * Using systemic or topical medications * Wears monovision or multifocal contact lenses * Any grade 2 or greater slit lamp findings * Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | Over-all follow-up visits for 2 week period | 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable. |
| Contact Lens High Contrast Visual Acuity | Over-all follow-up visits, 2 weeks | VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings | Over-all follow-up visits, 2 weeks | Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates |
Countries
Malaysia
Participant flow
Recruitment details
This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08
Pre-assignment details
220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Population enrolled at start of study | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Crossover Period | Ineligible | 1 | 1 |
| Crossover Period | Physician Decision | 1 | 0 |
| First Intervention | Lack of lenses | 0 | 1 |
| First Intervention | Positive slit lamp finding | 1 | 0 |
| Second Intervention | Developed a stye on upper lid | 1 | 0 |
| Second Intervention | Positive slit lamp finding | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 28.7 Years STANDARD_DEVIATION 7.19 |
| Race/Ethnicity, Customized Asian | 216 participants |
| Race/Ethnicity, Customized Black | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants |
| Race/Ethnicity, Customized White | 0 participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 215 | 0 / 216 |
| serious Total, serious adverse events | 0 / 215 | 0 / 216 |
Outcome results
Primary
Contact Lens High Contrast Visual Acuity
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
Time frame: Over-all follow-up visits, 2 weeks
Population: All eligible, dispensed eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SofLens DD Toric | Contact Lens High Contrast Visual Acuity | -0.007 LogMAR | Standard Deviation 0.0669 |
| Focus Dailies Toric | Contact Lens High Contrast Visual Acuity | -0.014 LogMAR | Standard Deviation 0.0696 |
Primary
Symptoms and Complaints
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Time frame: Over-all follow-up visits for 2 week period
Population: All eligible, dispensed eyes, Overall follow-up visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SofLens DD Toric | Symptoms and Complaints | Irritation | 83.0 Scores on a Scale | Standard Deviation 15.6 |
| SofLens DD Toric | Symptoms and Complaints | Comfort | 79.3 Scores on a Scale | Standard Deviation 17.1 |
| SofLens DD Toric | Symptoms and Complaints | Lens Cleanliness | 87.5 Scores on a Scale | Standard Deviation 12.7 |
| SofLens DD Toric | Symptoms and Complaints | Itching | 86.4 Scores on a Scale | Standard Deviation 14.9 |
| SofLens DD Toric | Symptoms and Complaints | Redness | 86.3 Scores on a Scale | Standard Deviation 14.9 |
| SofLens DD Toric | Symptoms and Complaints | Dryness | 77.4 Scores on a Scale | Standard Deviation 18 |
| SofLens DD Toric | Symptoms and Complaints | Lens Awareness | 78.8 Scores on a Scale | Standard Deviation 17.9 |
| SofLens DD Toric | Symptoms and Complaints | Lens Handling | 87.4 Scores on a Scale | Standard Deviation 13 |
| SofLens DD Toric | Symptoms and Complaints | Vision | 77.1 Scores on a Scale | Standard Deviation 19.1 |
| SofLens DD Toric | Symptoms and Complaints | Overall Impression | 78.7 Scores on a Scale | Standard Deviation 16.2 |
| SofLens DD Toric | Symptoms and Complaints | End of Day Comfort | 73.5 Scores on a Scale | Standard Deviation 19.6 |
| Focus Dailies Toric | Symptoms and Complaints | Overall Impression | 75.9 Scores on a Scale | Standard Deviation 17.5 |
| Focus Dailies Toric | Symptoms and Complaints | End of Day Comfort | 71.5 Scores on a Scale | Standard Deviation 19.9 |
| Focus Dailies Toric | Symptoms and Complaints | Lens Awareness | 75.6 Scores on a Scale | Standard Deviation 20.4 |
| Focus Dailies Toric | Symptoms and Complaints | Lens Cleanliness | 86.5 Scores on a Scale | Standard Deviation 13 |
| Focus Dailies Toric | Symptoms and Complaints | Irritation | 79.3 Scores on a Scale | Standard Deviation 19.6 |
| Focus Dailies Toric | Symptoms and Complaints | Redness | 81.5 Scores on a Scale | Standard Deviation 19.5 |
| Focus Dailies Toric | Symptoms and Complaints | Vision | 84.3 Scores on a Scale | Standard Deviation 14.6 |
| Focus Dailies Toric | Symptoms and Complaints | Comfort | 77.7 Scores on a Scale | Standard Deviation 17.6 |
| Focus Dailies Toric | Symptoms and Complaints | Itching | 83.9 Scores on a Scale | Standard Deviation 17.2 |
| Focus Dailies Toric | Symptoms and Complaints | Dryness | 73.7 Scores on a Scale | Standard Deviation 20.3 |
| Focus Dailies Toric | Symptoms and Complaints | Lens Handling | 76.1 Scores on a Scale | Standard Deviation 21.2 |
Secondary
Slit Lamp Findings
Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates
Time frame: Over-all follow-up visits, 2 weeks
Population: All dispensed eyes, over all follow-up visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SofLens DD Toric | Slit Lamp Findings | Slit Lamp Findings </= Grade 2 | 430 Eyes |
| SofLens DD Toric | Slit Lamp Findings | Slit Lamp Findings > Grade 2 | 0 Eyes |
| Focus Dailies Toric | Slit Lamp Findings | Slit Lamp Findings > Grade 2 | 2 Eyes |
| Focus Dailies Toric | Slit Lamp Findings | Slit Lamp Findings </= Grade 2 | 428 Eyes |