Myopia
Conditions
Keywords
myopia
Brief summary
The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.
Interventions
DEVICELotrafilcon B contact lens with color, automated
Silicone hydrogel contact lens with color manufactured via an automated process
DEVICELotrafilcon B contact lens with color, semi-automated
Silicone hydrogel contact lens with color manufactured via a semi-automated process
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to sign a written Informed Consent form. * Cylinder ≤ -0.75 diopter (D). * Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25. * Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses. * Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in an ophthalmic clinical trial. * Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator. * Pathologically dry eye. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction | Week 2 | The participant was asked, Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses. Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall lens fit | Dispense (Day 0) | Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight. |
| Contact Lens Corrected Visual Acuity (CLCVA) | Dispense (Day 0) | CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight. |
| Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA) | Week 2 | As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight. |
Outcome results
None listed