Refractive Errors
Conditions
Keywords
Contact Lens, Daily Wear, Vision Correction
Brief summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Detailed description
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.
Interventions
DEVICECLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
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. * Other protocol-specified 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 contact lenses. * Monovision contact lens wearers. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance VA (logMAR) With Study Lenses - Completed Eyes | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) | 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. |
| Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 8 investigative sites located in the US.
Pre-assignment details
Of the 119 enrolled, 1 subject was screen failed. This reporting group includes all enrolled and dispensed subjects/eyes (118/236).
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | 40 |
| LID018869 Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | 78 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Relocation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Biofinity | Total | LID018869 |
|---|---|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 7.3 | 33.9 years STANDARD_DEVIATION 7.5 | 34.4 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 112 Participants | 74 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 | 2 Participants | 14 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 101 Participants | 65 Participants |
| Region of Enrollment United States | 40 participants | 118 participants | 78 participants |
| Sex: Female, Male Female | 31 Participants | 88 Participants | 57 Participants |
| Sex: Female, Male Male | 9 Participants | 30 Participants | 21 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 / 118 | 0 / 156 | 0 / 78 | 0 / 80 | 0 / 40 |
| other Total, other adverse events | 0 / 118 | 0 / 156 | 0 / 78 | 0 / 80 | 0 / 40 |
| serious Total, serious adverse events | 0 / 118 | 0 / 156 | 0 / 78 | 0 / 80 | 0 / 40 |
Outcome results
Primary
Distance VA (logMAR) 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Population: This analysis population includes all enrolled and dispensed subjects/eyes that completed the study with data at corresponding in-person visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Dispense | -0.07 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Week 1 follow-up | -0.08 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Week 2 follow-up Snellen | -0.07 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 1 follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 2 follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 3 follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 2 follow-up | -0.07 logMAR | Standard Deviation 0.07 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Dispense | -0.07 logMAR | Standard Deviation 0.06 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 1 follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Week 1 follow-up | -0.07 logMAR | Standard Deviation 0.06 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Month 3 follow-up | -0.06 logMAR | Standard Deviation 0.11 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Completed Eyes | Week 2 follow-up Snellen | -0.07 logMAR | Standard Deviation 0.06 |
Primary
Distance VA (logMAR) 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
Population: This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early with data at corresponding in-person visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Week 2 follow-up | 0.00 logMAR | Standard Deviation 0 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Week 1 follow-up | -0.12 logMAR | Standard Deviation 0 |
| Biofinity | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Dispense | -0.06 logMAR | Standard Deviation 0.07 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Month 1 follow-up | -0.12 logMAR | Standard Deviation 0 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Week 1 follow-up | -0.12 logMAR | Standard Deviation 0 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Dispense | 0.00 logMAR | Standard Deviation 0 |
| LID018869 | Distance VA (logMAR) With Study Lenses - Discontinued Eyes | Week 2 follow-up | -0.12 logMAR | Standard Deviation 0 |