Myopia
Conditions
Keywords
Contact lens
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.
Interventions
DEVICEInvestigational Lens
Lenses worn on a daily wear basis for one week
DEVICEAir Optix Aqua lens
Lenses worn on a daily wear basis for one week
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.
Exclusion criteria
* Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * An active ocular disease, any corneal infiltrative response or are using any ocular medications. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance High Contrast logMAR Visual Acuity at 1 Week | Baseline & 1 week | Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings ≥ Grade 2 | 1 week | Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea. |
| Overall Comfort | 1 week | Comfort measured by participant on a scale of 0-100 with 100 being the most favorable. |
Countries
United States
Participant flow
Recruitment details
Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.
Pre-assignment details
66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population All eligible enrolled participants | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 2 - Crossover Intervention | Lost to Follow-up | 1 | 0 |
| Week 2 - Crossover Intervention | Missed crossover visit | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Distance High Contrast logMAR Visual Acuity at 1 Week
Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week
Time frame: Baseline & 1 week
Population: All eligible, dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lens | Distance High Contrast logMAR Visual Acuity at 1 Week | -0.031 logMAR | Standard Deviation 0.069 |
| Air Optix Aqua Lens | Distance High Contrast logMAR Visual Acuity at 1 Week | -0.015 logMAR | Standard Deviation 0.071 |
Secondary
Overall Comfort
Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.
Time frame: 1 week
Population: All eligible dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lens | Overall Comfort | 57.3 units on a scale | Standard Deviation 27.8 |
| Air Optix Aqua Lens | Overall Comfort | 80.8 units on a scale | Standard Deviation 27.2 |
Secondary
Slit Lamp Findings ≥ Grade 2
Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.
Time frame: 1 week
Population: All dispensed eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Lens | Slit Lamp Findings ≥ Grade 2 | 0 eyes |
| Air Optix Aqua Lens | Slit Lamp Findings ≥ Grade 2 | 0 eyes |