Myopia, Astigmatism, Refractive Error
Conditions
Keywords
contact lenses, contact lens solution, myopia, astigmatism
Brief summary
The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.
Detailed description
This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.
Interventions
Silicone hydrogel contact lenses, Phase 2
Silicone hydrogel contact lenses, Phase 2
Contact lens care system, Phase 2
DEVICEBIOTRUE®
Contact lens care system, Phase 2
Silicone hydrogel contact lenses worn for 30 days, Phase 1
DEVICEReNu® Multiplus®
Contact lens care system used for 30 days, Phase 1
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Read and understand the Participant Information Sheet; * Read, sign, and date the Informed Consent; * Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality; * Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria; * Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule; * Best corrected visual acuity of 6/9 or better in each eye; * Normal eyes with the exception of the need for visual correction; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used; * Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses); * Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects; * Systemic disease which might interfere with contact lens wear or produce dry eye side effects; * Systemic or ocular allergies which might interfere with contact lens wear; * Ocular disease which might interfere with contact lens wear; * Active ocular infection; * Use of any concomitant topical ocular medications during the study period; * Previous ocular surgery; * Pregnant, planning to become pregnant, or lactating at the time of enrollment; * Participation in an investigational drug or device study within 30 days of entering this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ex-Vivo Total Lipid Uptake Per Lens | Day 30 | The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LogMAR Time-Controlled Visual Acuity (TCVA) | Day 30 | Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20. |
| Overall Comfort Measured With Visual Analog Scale (VAS) | Day 30 | The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. |
| Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | Day 30 | The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean. |
| Average Exposure Speed | Day 30 | Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean. |
| Minimum Protected Area | Day 30 | Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean. |
| Overall Dryness Measured With Visual Analog Scale (VAS) | Day 30 | The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the United Kingdom.
Pre-assignment details
Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).
Participants by arm
| Arm | Count |
|---|---|
| Air Optix Aqua Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each | 34 |
| Acuvue Oasys Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each | 36 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 0 | 2 |
| Overall Study | Withdrew Consent | 0 | 1 |
Baseline characteristics
| Characteristic | Air Optix Aqua | Acuvue Oasys | Total |
|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 10.95 | 35.3 years STANDARD_DEVIATION 8.77 | 35.6 years STANDARD_DEVIATION 9.82 |
| Sex: Female, Male Female | 24 Participants | 29 Participants | 53 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 34 | 7 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 |
Outcome results
Primary
Mean Ex-Vivo Total Lipid Uptake Per Lens
The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Mean Ex-Vivo Total Lipid Uptake Per Lens | 7.198 micrograms | Standard Deviation 1.5014 |
| Acuvue Oasys | Mean Ex-Vivo Total Lipid Uptake Per Lens | 35.879 micrograms | Standard Deviation 1.8185 |
Secondary
Average Exposure Speed
Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Average Exposure Speed | 0.059 percent of area exposed/second | Standard Deviation 15.1175 |
| Acuvue Oasys | Average Exposure Speed | 0.105 percent of area exposed/second | Standard Deviation 24.4808 |
Secondary
LogMAR Time-Controlled Visual Acuity (TCVA)
Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Air Optix Aqua | LogMAR Time-Controlled Visual Acuity (TCVA) | High Contrast | 0.38 VA unit | Standard Deviation 1.058 |
| Air Optix Aqua | LogMAR Time-Controlled Visual Acuity (TCVA) | Low Contrast | -1.15 VA unit | Standard Deviation 1.213 |
| Acuvue Oasys | LogMAR Time-Controlled Visual Acuity (TCVA) | High Contrast | -0.14 VA unit | Standard Deviation 0.999 |
| Acuvue Oasys | LogMAR Time-Controlled Visual Acuity (TCVA) | Low Contrast | -1.60 VA unit | Standard Deviation 1.04 |
Secondary
Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | 3.316 seconds | Standard Deviation 2.6913 |
| Acuvue Oasys | Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | 2.918 seconds | Standard Deviation 2.4859 |
Secondary
Minimum Protected Area
Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Minimum Protected Area | 90.75 percentage of lens surface covered | Standard Deviation 15.99 |
| Acuvue Oasys | Minimum Protected Area | 77.79 percentage of lens surface covered | Standard Deviation 31.547 |
Secondary
Overall Comfort Measured With Visual Analog Scale (VAS)
The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Overall Comfort Measured With Visual Analog Scale (VAS) | 77.1 units on a scale | Standard Deviation 20.25 |
| Acuvue Oasys | Overall Comfort Measured With Visual Analog Scale (VAS) | 81.1 units on a scale | Standard Deviation 20.37 |
| BIOTRUE With Air Optix Aqua | Overall Comfort Measured With Visual Analog Scale (VAS) | 74.9 units on a scale | Standard Deviation 28.43 |
| BIOTRUE With Acuvue Oasys | Overall Comfort Measured With Visual Analog Scale (VAS) | 82.2 units on a scale | Standard Deviation 20.76 |
Secondary
Overall Dryness Measured With Visual Analog Scale (VAS)
The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Time frame: Day 30
Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Overall Dryness Measured With Visual Analog Scale (VAS) | 21.8 units on a scale | Standard Deviation 20.41 |
| Acuvue Oasys | Overall Dryness Measured With Visual Analog Scale (VAS) | 22.2 units on a scale | Standard Deviation 22.15 |
| BIOTRUE With Air Optix Aqua | Overall Dryness Measured With Visual Analog Scale (VAS) | 23.3 units on a scale | Standard Deviation 25.65 |
| BIOTRUE With Acuvue Oasys | Overall Dryness Measured With Visual Analog Scale (VAS) | 22.5 units on a scale | Standard Deviation 25.6 |