Ametropia, Myopia, Hyperopia, Astigmatism
Conditions
Brief summary
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
Detailed description
Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.
Interventions
DEVICESerafilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
DEVICESenofilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
DEVICECLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes. * Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months). * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion | Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment. | The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal \[+\] or temporal \[-\]). No hypothesis testing was prespecified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 7 investigative sites located in 1 country (US).
Pre-assignment details
This reporting group includes all participants exposed to any study lenses evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| LID226397, Then AOfAHP Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 48 |
| AOfAHP, Then LID226397 Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 44 |
| Total | 92 |
Baseline characteristics
| Characteristic | AOfAHP, Then LID226397 | Total | LID226397, Then AOfAHP |
|---|---|---|---|
| Age, Continuous | 32.0 years STANDARD_DEVIATION 9.6 | 32.3 years STANDARD_DEVIATION 9.6 | 32.7 years STANDARD_DEVIATION 9.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 21 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 15 Participants | 5 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 33 Participants | 76 Participants | 43 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 64 Participants | 35 Participants |
| Sex: Female, Male Female | 33 Participants | 55 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 37 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
| other Total, other adverse events | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
| serious Total, serious adverse events | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
Outcome results
Primary
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion
The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal \[+\] or temporal \[-\]). No hypothesis testing was prespecified for this endpoint.
Time frame: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.
Population: Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LID226397 | Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion | 100.0 percentage of lenses |
| AOfAHP | Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion | 100.0 percentage of lenses |