Refractive Errors, Myopia, Hyperopia
Conditions
Keywords
Contact lens, Vision correction, Visual acuity
Brief summary
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
Detailed description
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
Interventions
DEVICEModified delefilcon A contact lenses
Spherical soft daily disposable contact lens
Spherical soft daily disposable contact lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an approved Informed Consent form; * Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any eye condition that contraindicates contact lens wear, as determined by the Investigator; * Any eye surgery that contraindicates contact lens wear, as determined by the Investigator; * Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) * Monocular (only one eye with functional vision); * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Distance Visual Acuity (logMAR) | Day 1 Dispense, Day 7 Follow-Up | Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 5 investigative sites located in the United States.
Pre-assignment details
Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).
Participants by arm
| Arm | Count |
|---|---|
| MDACL, Then DACL MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. | 30 |
| DACL, Then MDACL DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First Week of Wear | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | MDACL, Then DACL | Total | DACL, Then MDACL |
|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 9.3 | 31.7 years STANDARD_DEVIATION 9 | 30.7 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 54 Participants | 26 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 | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 29 Participants | 55 Participants | 26 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 23 Participants | 47 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
High Contrast Distance Visual Acuity (logMAR)
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Time frame: Day 1 Dispense, Day 7 Follow-Up
Population: All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MDACL | High Contrast Distance Visual Acuity (logMAR) | Day 1 Dispense | -0.04 logMar | Standard Deviation 0.07 |
| MDACL | High Contrast Distance Visual Acuity (logMAR) | Day 7 Follow-Up | -0.05 logMar | Standard Deviation 0.07 |
| DACL | High Contrast Distance Visual Acuity (logMAR) | Day 1 Dispense | -0.04 logMar | Standard Deviation 0.07 |
| DACL | High Contrast Distance Visual Acuity (logMAR) | Day 7 Follow-Up | -0.05 logMar | Standard Deviation 0.07 |
mixed effects repeated measures model