Refractive Error
Conditions
Keywords
myopia, presbyopia
Brief summary
The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.
Interventions
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
DEVICEHabitual multifocal contact lenses
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent document; * Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire; * Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive); * Requires lenses within the power range of study lenses to be fitted; * Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution \[logMAR\]) or better in each eye at distance; * Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any eye condition that contraindicates wearing contact lenses as determined by the Investigator; * Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator; * Monocular (only one eye functional) or fit with only 1 lens; * Fitted with monovision; * Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.); * History of herpetic keratitis, ocular surgery, or irregular cornea; * Currently wearing DT1 MF contact lenses; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | Day 14, each product | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Day 14, each product | The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology. |
Participant flow
Recruitment details
Subjects were recruited from 11 study centers located in the United States.
Pre-assignment details
Of the 170 enrolled, 2 subjects were exited as screen failures prior to randomization. An additional 2 subjects were randomized in error but not exposed. This reporting group includes all randomized and exposed subjects (166).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment. | 166 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 14 Days of Wear | Inclusion criteria not met | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 5.14 |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 170 | 0 / 165 | 0 / 166 |
| other Total, other adverse events | 0 / 170 | 0 / 165 | 0 / 166 |
| serious Total, serious adverse events | 0 / 170 | 0 / 165 | 0 / 166 |
Outcome results
Primary
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
Time frame: Day 14, each product
Population: Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DT1 MF | Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | -0.07 logMAR | Standard Deviation 0.1 |
| Habitual MF | Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | -0.09 logMAR | Standard Deviation 0.1 |
Secondary
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.
Time frame: Day 14, each product
Population: Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DT1 MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Period One | 9.9 units on a scale | Standard Deviation 5.4 |
| DT1 MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Period Two | 11.6 units on a scale | Standard Deviation 6.3 |
| DT1 MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Overall | 10.7 units on a scale | Standard Deviation 5.9 |
| Habitual MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Period One | 17.0 units on a scale | Standard Deviation 7.1 |
| Habitual MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Period Two | 13.0 units on a scale | Standard Deviation 6.2 |
| Habitual MF | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Overall | 14.9 units on a scale | Standard Deviation 6.9 |