Refractive Ametropia
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Detailed description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
Interventions
DEVICELID015385 soft contact lenses
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
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
* Able to understand and sign an Informed Consent Form. * Willing to attend all scheduled study visits as required per protocol. * Willing and able to wear assigned study lenses as required per protocol. * Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week. * Manifest cylinder ≤ 0.75 diopter (D) in each eye. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. * History of eye surgery, including refractive surgery. * Currently pregnant or breast-feeding. * Monovision contact lens wearers. * Daily disposable contact lens wearers. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up | 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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. |
| Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up | 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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. |
| Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | Up to Month 12 | Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity). |
Countries
United States
Participant flow
Recruitment details
The study population consisted of a Primary cohort, including subjects of any race/ethnic background at 35 Primary cohort sites, and a Supplemental cohort, including subjects of Chinese race only at 7 Supplemental cohort sites.
Pre-assignment details
Of the 675 enrolled, 30 participants were exited from the study as screen failures prior to randomization. This reporting group includes all enrolled and dispensed participants (645).
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. | 323 |
| LID015385 LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol. | 322 |
| Total | 645 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 7 |
| Overall Study | Did not meet inclusion criteria | 1 | 1 |
| Overall Study | Early termination | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Reasons Related to COVID-19 | 5 | 8 |
| Overall Study | Witihdrew Consent | 16 | 16 |
Baseline characteristics
| Characteristic | Biofinity | Total | LID015385 |
|---|---|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 8.3 | 33.8 years STANDARD_DEVIATION 8.9 | 34.2 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 60 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 295 Participants | 584 Participants | 289 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 70 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 37 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 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 | 8 Participants | 17 Participants | 9 Participants |
| Race (NIH/OMB) White | 254 Participants | 516 Participants | 262 Participants |
| Region of Enrollment United States | 323 participants | 645 participants | 322 participants |
| Sex: Female, Male Female | 202 Participants | 399 Participants | 197 Participants |
| Sex: Female, Male Male | 121 Participants | 246 Participants | 125 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 / 645 | 0 / 646 | 0 / 323 | 0 / 644 | 0 / 322 |
| other Total, other adverse events | 0 / 645 | 0 / 646 | 0 / 323 | 0 / 644 | 0 / 322 |
| serious Total, serious adverse events | 0 / 645 | 4 / 646 | 2 / 323 | 0 / 644 | 3 / 322 |
Outcome results
Primary
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Population: This analysis population includes all enrolled dispensed subjects/eyes completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Hour 24 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 3 Follow-up | -0.06 logMAR | Standard Deviation 0.07 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 1 Follow-up | -0.05 logMAR | Standard Deviation 0.07 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 6 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 9 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 2 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 12 Follow-up/Exit | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 12 Follow-up/Exit | -0.05 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Hour 24 Follow-up | -0.05 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 1 Follow-up | -0.05 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 2 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 3 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 6 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 9 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
Primary
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Population: This analysis population includes all enrolled and dispensed subjects/eyes not completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense | -0.04 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Hour 24 Follow-up | -0.03 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 1 Follow-up | -0.04 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 2 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 3 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 6 Follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 9 Follow-up | -0.08 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 9 Follow-up | -0.12 logMAR | Standard Deviation 0 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense | -0.06 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 2 Follow-up | -0.04 logMAR | Standard Deviation 0.11 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Hour 24 Follow-up | -0.05 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 6 Follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 1 Follow-up | -0.05 logMAR | Standard Deviation 0.08 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 3 Follow-up | -0.02 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
Primary
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
Time frame: Up to Month 12
Population: This analysis population includes all enrolled subjects who were also dispensed. This outcome measure was pre-specified for the Primary Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biofinity | Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | 0.0258 proportion of eyes |
| LID015385 | Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | 0.0103 proportion of eyes |
Generalized linear model