Refractive Errors, Myopia, Hypermetropia
Conditions
Brief summary
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.
Interventions
DEVICELotrafilcon B contact lenses with added wetting agent
Silicone hydrogel contact lenses
Habitual silicone hydrogel contact lenses
DEVICEPOLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Multi-purpose disinfecting solution for contact lens care
DEVICEHydrogen peroxide-based contact lens solution with added wetting agent
Solution for contact lens cleaning and disinfecting
Habitual silicone hydrogel contact lenses
Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
Habitual silicone hydrogel contact lenses
DEVICEHabitual Multi-Purpose Solution (HMPS)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign informed consent document; * Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses; * Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add \<+0.50 D in each eye; * Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available; * Current user of an MPS (excluding OFPM) to care for lenses; * Willing to answer text messages on a daily basis during the study; * Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits; * Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study; * Other protocol specific inclusion criteria may apply.
Exclusion criteria
* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week); * Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear; * History of herpetic keratitis, corneal surgery or irregular cornea; * Prior refractive surgery; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days; * Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Known pregnancy or lactating; * Other protocol specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ex Vivo Total Cholesterol Uptake at Day 30 | Day 30 | The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).
Pre-assignment details
Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.
Participants by arm
| Arm | Count |
|---|---|
| AOHG/CCP Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent | 60 |
| AOHG/OFPM Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent | 64 |
| Biofinity/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS | 34 |
| Vita/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS | 25 |
| Ultra/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS | 23 |
| Oasys/HMPS Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS | 46 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 7 | 27.8 years STANDARD_DEVIATION 6 | 28.2 years STANDARD_DEVIATION 5.9 | 28.2 years STANDARD_DEVIATION 5.7 | 28.8 years STANDARD_DEVIATION 7.2 | 30.4 years STANDARD_DEVIATION 8.2 | 28.4 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 62 Participants | 33 Participants | 24 Participants | 22 Participants | 43 Participants | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 39 Participants | 49 Participants | 22 Participants | 17 Participants | 17 Participants | 35 Participants | 179 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 12 Participants | 8 Participants | 6 Participants | 11 Participants | 73 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 58 | 0 / 130 | 0 / 65 | 0 / 258 | 0 / 129 |
| other Total, other adverse events | 0 / 116 | 0 / 58 | 0 / 130 | 0 / 65 | 0 / 258 | 0 / 129 |
| serious Total, serious adverse events | 0 / 116 | 0 / 58 | 0 / 130 | 0 / 65 | 0 / 258 | 0 / 129 |
Outcome results
Primary
Ex Vivo Total Cholesterol Uptake at Day 30
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
Time frame: Day 30
Population: Full Analysis Set with cholesterol uptake measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AOHG/CCP | Ex Vivo Total Cholesterol Uptake at Day 30 | 0.28 μg | Standard Deviation 0.18 |
| AOHG/OFPM | Ex Vivo Total Cholesterol Uptake at Day 30 | 0.28 μg | Standard Deviation 0.48 |
| Biofinity/HMPS | Ex Vivo Total Cholesterol Uptake at Day 30 | 2.17 μg | Standard Deviation 1.47 |
| Vita/HMPS | Ex Vivo Total Cholesterol Uptake at Day 30 | 4.18 μg | Standard Deviation 3.25 |
| Ultra/HMPS | Ex Vivo Total Cholesterol Uptake at Day 30 | 2.07 μg | Standard Deviation 1.48 |
| Oasys/HMPS | Ex Vivo Total Cholesterol Uptake at Day 30 | 2.19 μg | Standard Deviation 2.69 |
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model
p-value: <0.0001General Linear Model