Refractive Errors, Myopia, Hyperopia
Conditions
Keywords
Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear
Brief summary
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
Detailed description
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
Interventions
DEVICELehfilcon A contact lens
Investigational silicone hydrogel contact lens
DEVICEComfilcon A contact lens
Commercially available silicone hydrogel contact lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an IRB/IEC approved Informed Consent form. * Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week. * Best corrected visual acuity of 20/25 or better in each eye. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator. * Any habitual wear of Biofinity contact lenses. * Pregnant or breast-feeding. * Other protocol specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses | Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit | 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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| LID018869 (OD) / Biofinity (OS) Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear | 18 |
| Biofinity (OD) / LID018869 (OS) Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Biofinity (OD) / LID018869 (OS) | Total | LID018869 (OD) / Biofinity (OS) |
|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 10.5 | 33.2 years STANDARD_DEVIATION 9.2 | 32.4 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 34 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Distance Visual Acuity (VA) With Study Lenses
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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LID018869 | Distance Visual Acuity (VA) With Study Lenses | Day 1 Dispense | -0.03 logMAR | Standard Deviation 0.05 |
| LID018869 | Distance Visual Acuity (VA) With Study Lenses | Day 2 Follow-up | -0.03 logMAR | Standard Deviation 0.05 |
| LID018869 | Distance Visual Acuity (VA) With Study Lenses | Week 1 Follow-up/Exit | -0.03 logMAR | Standard Deviation 0.05 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses | Day 1 Dispense | -0.04 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses | Day 2 Follow-up | -0.03 logMAR | Standard Deviation 0.05 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses | Week 1 Follow-up/Exit | -0.03 logMAR | Standard Deviation 0.05 |