Refractive Errors
Conditions
Keywords
Vision Correction, Contact Lens
Brief summary
The purpose of this clinical study is to evaluate 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.
Detailed description
Subjects will be expected to 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 3-4 months in this daily wear clinical study.
Interventions
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
DEVICECLEAR CARE
Hydrogen peroxide-based contact lens 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: * Successful wear of spherical daily wear frequent replacement 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 equal to or less than 0.75 diopter (D) in each eye; * Best spectacle corrected visual acuity (using manifest refraction) of 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; * Habitually wearing Biofinity lenses; * Monovision or multifocal contact lens wearers; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up | 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 at Week 1 Follow-Up | 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, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 14 sites located in the United States.
Pre-assignment details
Of the 158 enrolled, 11 subjects were not dispensed study lenses and were exited from the study as screen failures. This reporting group includes all subjects who were dispensed study lenses (147).
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 49 |
| LID018869 Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection. | 92 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Travel | 3 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | LID018869 | Total | Biofinity |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 10.8 | 33.2 years STANDARD_DEVIATION 10.4 | 33.6 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 136 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Chinese | 61 Participants | 92 Participants | 31 Participants |
| Race/Ethnicity, Customized Japanese | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Korean | 6 Participants | 10 Participants | 4 Participants |
| Race/Ethnicity, Customized Other Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 32 Participants | 12 Participants |
| Sex: Female, Male Female | 61 Participants | 97 Participants | 36 Participants |
| Sex: Female, Male Male | 31 Participants | 44 Participants | 13 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 / 147 | 0 / 100 | 0 / 50 | 0 / 194 | 0 / 97 |
| other Total, other adverse events | 0 / 147 | 0 / 100 | 0 / 50 | 0 / 194 | 0 / 97 |
| serious Total, serious adverse events | 0 / 147 | 0 / 100 | 0 / 50 | 0 / 194 | 0 / 97 |
Outcome results
Primary
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at 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.
Time frame: Week 1 Follow-Up
Population: PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Biofinity | Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up | -0.06 logMAR | Standard Error 0 |
| LID018869 | Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up | -0.06 logMAR | Standard Error 0 |
95% CI: [-0.01, 0.01]Mixed effects repeated measures model
Secondary
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at 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, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.
Time frame: Week 1 Follow-Up
Population: PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biofinity | Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up | 98.8 percentage of subjects |
| LID018869 | Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up | 97.0 percentage of subjects |
95% CI: [-0.04, 0.02]Generalized linear mixed model