Refractive Errors, Astigmatism
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Detailed description
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
Interventions
FDA-cleared silicone hydrogel toric contact lenses used as indicated
Commercially available silicone hydrogel toric contact lenses used as indicated
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
Key Inclusion Criteria: * Successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months; * Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye. * Able to wear contact lenses within the range of available sphere & cylinder power and axes. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Daily disposable contact lens wearers. * Monovision and multifocal contact lens wearers. * Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses | Day 1 and Day 30, each wear period (approximately 30 days) | Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 7 investigative sites located in the United States.
Pre-assignment details
Of the 76 subjects enrolled in the study (i.e., signed informed consent), 2 subjects were exited prior to randomization as screen failures, and 1 randomized subject withdrew prior to exposure to the study lenses. This reporting group includes all randomized subjects/eyes (74/148).
Participants by arm
| Arm | Count |
|---|---|
| LID205255 Toric, Then Biofinity Toric Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 36 |
| Biofinity Toric, Then LID205255 Toric Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (Approx 30 Days) | Adverse Event | 0 | 1 |
| First Wear Period (Approx 30 Days) | Withdrawal by Subject | 0 | 1 |
| First Wear Period (Approx 30 Days) | Withdrawal by Subject Prior to Exposure to the Study Lenses | 1 | 0 |
| Second Wear Period (Approx 30 Days) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric | Total |
|---|---|---|---|
| Age, Continuous | 32.9 year STANDARD_DEVIATION 8.3 | 35.8 year STANDARD_DEVIATION 10.2 | 34.4 year STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 32 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 32 Participants | 63 Participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 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 / 73 | 0 / 142 | 0 / 71 | 0 / 146 | 0 / 73 |
| other Total, other adverse events | 0 / 73 | 0 / 142 | 0 / 71 | 0 / 146 | 0 / 73 |
| serious Total, serious adverse events | 0 / 73 | 0 / 142 | 0 / 71 | 0 / 146 | 0 / 73 |
Outcome results
Primary
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Time frame: Day 1 and Day 30, each wear period (approximately 30 days)
Population: All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing data at the respective visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LID205255 Toric | Distance Visual Acuity (VA) With Study Lenses | Day 1 | -0.06 logMAR | Standard Deviation 0.09 |
| LID205255 Toric | Distance Visual Acuity (VA) With Study Lenses | Day 30 | -0.08 logMAR | Standard Deviation 0.09 |
| Biofinity Toric | Distance Visual Acuity (VA) With Study Lenses | Day 1 | -0.07 logMAR | Standard Deviation 0.09 |
| Biofinity Toric | Distance Visual Acuity (VA) With Study Lenses | Day 30 | -0.06 logMAR | Standard Deviation 0.08 |