Ametropia, Astigmatism
Conditions
Keywords
Contact lenses, Myopia
Brief summary
The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Detailed description
Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.
Interventions
Commercially available soft contact lenses worn as indicated
Commercially available soft contact lenses) worn as indicated
DEVICECLEAR CARE
Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated
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 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 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 0.10 logMAR in each eye; * Willing and able to wear the study lenses as specified in the protocol; * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates; * Monovision and multifocal contact lens wearers; * Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent; * Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Distance Visual Acuity With Study Lenses at Day 30 | Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment. | Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight. |
Countries
United States
Participant flow
Pre-assignment details
Of the 67 enrolled, 1 participant was discontinued following randomization but prior to exposure to the study lenses. This reporting group includes all participants exposed to any study lenses evaluated in this study (66).
Participants by arm
| Arm | Count |
|---|---|
| T30fA, Then Biofinity Toric Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. | 34 |
| Biofinity Toric, Then T30fA Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. | 32 |
| Total | 66 |
Baseline characteristics
| Characteristic | Total | T30fA, Then Biofinity Toric | Biofinity Toric, Then T30fA |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 8 | 32.6 years STANDARD_DEVIATION 7.9 | 31.9 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 30 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 34 Participants | 17 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 1 Participants | 3 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 Other | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 12 Participants | 12 Participants |
| Region of Enrollment United States | 66 Participants | 34 Participants | 32 Participants |
| Sex: Female, Male Female | 41 Participants | 17 Participants | 24 Participants |
| Sex: Female, Male Male | 25 Participants | 17 Participants | 8 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 / 66 | 0 / 132 | 0 / 66 | 0 / 132 | 0 / 66 |
| other Total, other adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 132 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 132 | 0 / 66 |
Outcome results
Primary
Mean Distance Visual Acuity With Study Lenses at Day 30
Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.
Time frame: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.
Population: Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response. Note, One subject in the Biofinity Toric arm lost a lens on the way to the visit. Hence, the assessment was taken on 1 eye only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T30fA | Mean Distance Visual Acuity With Study Lenses at Day 30 | -0.07 logMAR | Standard Deviation 0.06 |
| Biofinity Toric | Mean Distance Visual Acuity With Study Lenses at Day 30 | -0.06 logMAR | Standard Deviation 0.06 |