Contact Lens Complication, Dry Eye
Conditions
Keywords
Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
Brief summary
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Detailed description
Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.
Interventions
DEVICETotal30 Sphere Contact Lenses
Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
Sponsors
Alcon Research
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Current contact lens wearers who have 20/20 visual acuity or better * Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10) * Astigmatism better than or equal to 0.50 D in each eye * Must have regularly worn 2 week or monthly contact lenses within the past 6 months * Must provide a glasses prescription that is is less than 3 years old * Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day
Exclusion criteria
* Past or Current hard CL use * Any known systemic health conditions that are thought to alter tear film physiology * History of viral eye disease * History of ocular surgery * History of severe ocular trauma * Active ocular infection or inflammation * Currently using isotretinoin-derivatives * Currently using ocular medications * Currently using rewetting drops or artificial tear * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Ocular Comfort | 1 month | A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total30 Sphere Contact Lenses All qualified participants will be refit into Total30 Sphere contact lenses.
Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Total30 Sphere Contact Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous Total30 Participants | 26.2 Years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 31 Participants |
| Region of Enrollment United States | 48 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Visual Analog Scale (VAS) Ocular Comfort
A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).
Time frame: 1 month
Population: Total30 Contact Lens Wearing Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | Day 1: Comfort at Hour 16 | 36.66 units on a scale | Standard Deviation 19.11 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | Day 2: Comfort at Hour 16 | 38.06 units on a scale | Standard Deviation 14.71 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | Day 3: Comfort at hour 16 | 33.68 units on a scale | Standard Deviation 22.49 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | Day 4: Comfort at hour 16 | 39.36 units on a scale | Standard Deviation 13.95 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | Day 5: Comfort at hour 16 | 31.26 units on a scale | Standard Deviation 24.73 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | 2 weeks: Comfort at hour 16 | 33.84 units on a scale | Standard Deviation 23.15 |
| Total30 Sphere Contact Lenses | Visual Analog Scale (VAS) Ocular Comfort | 1 month: Comfort at hour 16 | 33.21 units on a scale | Standard Deviation 22.39 |
p-value: 0.07ANOVA