Refractive Ametropia
Conditions
Keywords
Myopia
Brief summary
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
Detailed description
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
Interventions
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
DEVICECLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye. * Willing to stop wearing habitual contact lenses for the duration of study participation. * Other protocol-specific inclusion criteria may apply.
Exclusion criteria
* Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator. * Habitual wear of AOHP contact lenses. * Habitual wear of any daily disposable contact lenses. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance VA With Study Lenses at Week 1 | Week 1 of each lens product worn during the corresponding crossover period | Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 15 investigative sites located in the United States.
Pre-assignment details
Of the 190 enrolled, 3 participants were exited prior to randomization as screen failures. Of the 187 randomized, 1 participant was discontinued prior to exposure to the study lenses due to ocular pre-treatment adverse events. This reporting group includes all participants exposed to any study lenses (186).
Participants by arm
| Arm | Count |
|---|---|
| LID022821, Then AOHP Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. | 94 |
| AOHP, Then LID022821 Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. | 92 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period, Approximately 7 Days | Adverse Event | 0 | 1 |
| First Wear Period, Approximately 7 Days | Withdrawal by Subject | 1 | 2 |
| Second Wear Period, Approximately 7 Days | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | LID022821, Then AOHP | AOHP, Then LID022821 | Total |
|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 8.6 | 33.9 years STANDARD_DEVIATION 9 | 34.0 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 20 Participants | 19 Participants | 39 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 88 Participants | 85 Participants | 173 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 62 Participants | 128 Participants |
| Sex: Female, Male Female | 60 Participants | 64 Participants | 124 Participants |
| Sex: Female, Male Male | 34 Participants | 28 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 0 / 364 | 0 / 182 | 0 / 370 | 0 / 185 |
| other Total, other adverse events | 0 / 186 | 0 / 364 | 0 / 182 | 0 / 370 | 0 / 185 |
| serious Total, serious adverse events | 0 / 186 | 0 / 364 | 0 / 182 | 0 / 370 | 0 / 185 |
Outcome results
Primary
Least Squares Mean Distance VA With Study Lenses at Week 1
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Week 1 of each lens product worn during the corresponding crossover period
Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this study with data at Week 1 visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LID022821 | Least Squares Mean Distance VA With Study Lenses at Week 1 | -0.11 logMAR | Standard Error 0.005 |
| AOHP | Least Squares Mean Distance VA With Study Lenses at Week 1 | -0.10 logMAR | Standard Error 0.005 |