Refractive Errors
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Detailed description
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
Interventions
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
DEVICEMulti-purpose disinfection solution
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
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
* Sign Informed Consent document. * Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any eye condition or disease or use of medication that contraindicates contact lens wear. * Eye surgery, irregular cornea, eye injury as specified in the protocol. * Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment. * Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear. * Habitually wears Biofinity contact lenses. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance VA (logMAR) With Study Lenses | Day 30 after a minimum of 6 hours of wear, each product | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 3 investigative sites located in the US.
Pre-assignment details
This reporting group includes all randomized subjects/eyes (36/72) as treated. Note: Two subjects received investigational product misallocations and were exposed to the incorrect study product in the sequence.
Participants by arm
| Arm | Count |
|---|---|
| Overall LID017569 and Biofinity contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 8 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 / 72 | 0 / 36 | 0 / 72 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 72 | 0 / 36 | 0 / 72 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 72 | 0 / 36 | 0 / 72 | 0 / 36 |
Outcome results
Primary
Distance VA (logMAR) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 30 after a minimum of 6 hours of wear, each product
Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID017569 | Distance VA (logMAR) With Study Lenses | -0.13 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance VA (logMAR) With Study Lenses | -0.14 logMAR | Standard Deviation 0.06 |