Myopia, Refractive Errors
Conditions
Keywords
soft contact lenses, vision, eyesight
Brief summary
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
Interventions
Investigational daily disposable soft contact lenses
Commercially available daily disposable soft contact lenses
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
* Understand and sign an Informed Consent Form; * Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Best-corrected visual acuity (BCVA) 20/25 or better in each eye; * Willing to stop wearing habitual contact lenses for the duration of study participation; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator; * Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; * Refractive, ocular, or intraocular surgery, as specified in the protocol; * Eye condition or injury, as specified in the protocol; * Current or history of intolerance, hypersensitivity, or allergy to any component of the study products; * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear; * Currently wearing clariti® 1 day contact lenses; * Habitually wearing monovision or multifocal lenses during the last 3 months; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision | Day 8, each product | Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 1 investigative site located in the United States.
Pre-assignment details
A total of 22 subjects signed informed consent to participate in the study. This reporting group includes all randomized and exposed subjects (22).
Participants by arm
| Arm | Count |
|---|---|
| Overall Verofilcon A and somofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, Second Week of Wear | Family emergency | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 22 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Overall Quality of Vision
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Time frame: Day 8, each product
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD T2 | Overall Quality of Vision | 9.2 units on a scale | Standard Deviation 1 |
| Clariti 1 Day | Overall Quality of Vision | 8.6 units on a scale | Standard Deviation 1.5 |