Hyperopia, Myopia, Refractive Errors
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