Refractive Errors
Conditions
Keywords
Contact Lens, Extended Wear, Overnight Wear, Contralateral Wear, Vision Correction
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 following 1 week of extended wear.
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 Baseline/Dispense; Day 2 Follow-up; 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
DEVICELID011121 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
SINGLE_GROUP
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 Institutional Review Board/Ethics Committee-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 per week and in an extended wear modality a minimum of 1 night per week. * Best Corrected Visual Acuity (BCVA) 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. * Current Biofinity© lens wearer. * Pregnant or breast-feeding. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) With Study Lenses, Collected by Eye | Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit | 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 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 2 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| LID011121 (OD) / Biofinity (OS) LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear | 10 |
| Biofinity (OD) / LID011121 (OS) Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | LID011121 (OD) / Biofinity (OS) | Total | Biofinity (OD) / LID011121 (OS) |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 7.7 | 40.8 years STANDARD_DEVIATION 9.5 | 38.3 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 20 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 17 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 22 participants | 12 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 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 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Visual Acuity (VA) With Study Lenses, Collected by Eye
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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LID011121 | Visual Acuity (VA) With Study Lenses, Collected by Eye | Week 1 Follow-up/Exit | -0.06 logMAR | Standard Deviation 0.07 |
| LID011121 | Visual Acuity (VA) With Study Lenses, Collected by Eye | Day 1 Dispense | -0.04 logMAR | Standard Deviation 0.06 |
| LID011121 | Visual Acuity (VA) With Study Lenses, Collected by Eye | Day 2 Follow-up | -0.06 logMAR | Standard Deviation 0.11 |
| Biofinity | Visual Acuity (VA) With Study Lenses, Collected by Eye | Day 2 Follow-up | -0.09 logMAR | Standard Deviation 0.06 |
| Biofinity | Visual Acuity (VA) With Study Lenses, Collected by Eye | Day 1 Dispense | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Visual Acuity (VA) With Study Lenses, Collected by Eye | Week 1 Follow-up/Exit | -0.08 logMAR | Standard Deviation 0.06 |