Hyperopia, Myopia
Conditions
Brief summary
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
Interventions
DEVICELotrafilcon B
commercially available contact lens
DEVICElotrafilcon B with Hydraluxe
commercially available contact lens
Sponsors
Alcon Research
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Habitual prescription +5.00 D to -6.00 D * 18-35 years of age * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * Vertex corrected refractive cylinder must be -0.75 or less. * Visual acuity best correctable to 20/25 or better for each eye * The subject must read and sign the Informed Consent form. * Mesopic pupil size \>5.00 mm.
Exclusion criteria
* active condition that would prevent contact lens wear * history of issues of eye alignment or binocularity by self-report * doctor diagnosed, self-reported accommodative or binocular vision issues * doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Higher Order Aberrations | 0-12 hours | Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Stability of Vision Rating | 0-12 hours | Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision) |
| Image Quality Metrics | 0-12 hours | Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe First intervention (2+/-1day) Second intervention (2+/-1day) | 12 |
| Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B First intervention (2+/-1day) Second intervention (2+/-1day) | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Lotrafilcon B First, Then Lotrafilcon B With Hydraluxe | Lotrafilcon B With Hydraluxe First, Then Lotrafilcon B |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 12 Participants | 12 Participants |
| Age, Continuous | 24.29 years STANDARD_DEVIATION 3.61 | 24.25 years STANDARD_DEVIATION 3.57 | 24.33 years STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 10 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 12 Participants | 8 Participants |
| Region of Enrollment United States | 24 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 17 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Higher Order Aberrations
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time frame: 0-12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Higher Order Aberrations | 0.001646 microns | Standard Deviation 0.028867 |
| Lotrafilcon B With Hydraluxe | Higher Order Aberrations | 0.002629 microns | Standard Deviation 0.044299 |
Secondary
Image Quality Metrics
Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Time frame: 0-12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Image Quality Metrics | 0.015134 microns | Standard Deviation 0.051825 |
| Lotrafilcon B With Hydraluxe | Image Quality Metrics | 0.013899 microns | Standard Deviation 0.036077 |
Secondary
Subjective Stability of Vision Rating
Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)
Time frame: 0-12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Subjective Stability of Vision Rating | -5.833 score on a scale | Standard Deviation 10.8 |
| Lotrafilcon B With Hydraluxe | Subjective Stability of Vision Rating | -2.500 score on a scale | Standard Deviation 9.78 |
Comparison: Change in ratings over timep-value: 0.0023Friedman Test
Comparison: change in ratings over timep-value: 0.4679Friedman Test