Refractive Errors
Conditions
Keywords
Contact Lenses, Myopia
Brief summary
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
Detailed description
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
Interventions
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
DEVICEAOSEPT PLUS with HydraGlyde
Hydrogen peroxide-based cleaning and disinfecting solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience. * Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day. * Willing to NOT use rewetting/lubricating drops at any time during the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial. * Habitual AOHP contact lens wearers (in the past 3 months). * Monovision wear during the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance VA (logMAR) With Study Lenses | Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period) | Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in 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. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited from one investigative site located in the United Kingdom.
Pre-assignment details
This reporting group includes all enrolled subjects/eyes.
Participants by arm
| Arm | Count |
|---|---|
| TOTAL30, Then AOHP Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. | 18 |
| AOHP, Then TOTAL30 Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period, Day 14 or Day 28 | Adverse Event | 1 | 0 |
| First Wear Period, Day 14 or Day 28 | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | TOTAL30, Then AOHP | AOHP, Then TOTAL30 |
|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 11 | 28.8 years STANDARD_DEVIATION 11.3 | 32.9 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 3 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Female | 26 Participants | 11 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 3 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 / 36 | 0 / 68 | 0 / 34 | 0 / 70 | 0 / 35 |
| other Total, other adverse events | 0 / 36 | 0 / 68 | 0 / 34 | 0 / 70 | 0 / 35 |
| serious Total, serious adverse events | 0 / 36 | 0 / 68 | 0 / 34 | 0 / 70 | 0 / 35 |
Outcome results
Primary
Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in 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. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time frame: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
Population: Safety analysis set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOTAL30 | Distance VA (logMAR) With Study Lenses | Dispense | -0.08 logMAR | Standard Deviation 0.07 |
| TOTAL30 | Distance VA (logMAR) With Study Lenses | Follow Up | -0.07 logMAR | Standard Deviation 0.09 |
| AOHP | Distance VA (logMAR) With Study Lenses | Dispense | -0.10 logMAR | Standard Deviation 0.07 |
| AOHP | Distance VA (logMAR) With Study Lenses | Follow Up | -0.07 logMAR | Standard Deviation 0.07 |