Refractive Errors, Myopia, Hyperopia
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Detailed description
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
Interventions
DEVICELID015385 contact lenses
Investigational soft contact lenses
Commercially available soft contact lenses
DEVICECLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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: * Understand and sign an IRB/IEC approved Informed Consent form. * Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol. * Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * Manifest cylinder ≤ 0.75 diopter (D) in each eye. * Best spectacle corrected visual acuity 20/20 or better in each eye. * 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. * Monovision contact lens wear. * Any habitual wear of Biofinity lenses. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | Week 1 Follow-Up | Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | Week 1 Follow-Up, at least 4 hours after lens insertion | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 18 investigative sites located in the United States.
Pre-assignment details
Of the 249 participants enrolled in this study, 15 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects/eyes (234/468).
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. | 75 |
| LID015385 LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection. | 145 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Unable to attend study visits due to COVID-19 pandemic | 1 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | LID015385 | Total | Biofinity |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 9.1 | 31.8 years STANDARD_DEVIATION 8.8 | 32.7 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 211 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Chinese | 64 Participants | 96 Participants | 32 Participants |
| Race/Ethnicity, Customized Japanese | 7 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized Korean | 7 Participants | 11 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 65 Participants | 95 Participants | 30 Participants |
| Region of Enrollment United States | 145 participants | 220 participants | 75 participants |
| Sex: Female, Male Female | 105 Participants | 157 Participants | 52 Participants |
| Sex: Female, Male Male | 40 Participants | 63 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 / 234 | 0 / 156 | 0 / 78 | 0 / 312 | 0 / 156 |
| other Total, other adverse events | 0 / 234 | 0 / 156 | 0 / 78 | 0 / 312 | 0 / 156 |
| serious Total, serious adverse events | 0 / 234 | 0 / 156 | 0 / 78 | 0 / 312 | 0 / 156 |
Outcome results
Primary
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time frame: Week 1 Follow-Up
Population: PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Biofinity | Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | -0.06 logMAR | Standard Error 0 |
| LID015385 | Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | -0.05 logMAR | Standard Error 0 |
95% CI: [0, 0.02]Mixed effects repeated measures
Secondary
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.
Time frame: Week 1 Follow-Up, at least 4 hours after lens insertion
Population: PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biofinity | Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | 98.1 percentage of subjects |
| LID015385 | Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | 97.0 percentage of subjects |
95% CI: [-0.06, 0.04]Farrington-Manning