Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).
Interventions
DEVICEDelefilcon A Multifocal Contact Lenses with Molded Mark
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an Informed Consent document; * Current wearer of commercial DAILIES TOTAL1® contact lenses; * Have spectacles in current prescription available to be worn in conjunction with the investigational product; * Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening) * Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Eye injury in either eye within 12 weeks prior to study enrollment; * Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated; * History of herpetic keratitis, refractive surgery or irregular cornea; * A pathologically dry eye that precludes contact lens wear; * Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days; * Monocular (only 1 eye with functional vision); * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular Discomfort Device-related Adverse Events (AE) | Day 1 at Hour 9 | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as Related to study device and deemed to be related to ocular discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Staining | Day 1 at Hour 9 | Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis. |
| Limbal Hyperemia | Day 1 at Hour 9 | Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 5 study centers located in the United States.
Pre-assignment details
Of the 87 enrolled, 7 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).
Participants by arm
| Arm | Count |
|---|---|
| DT1 MF MM Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours | 40 |
| DT1 MF Delefilcon A multifocal contact lenses worn bilaterally for 9 hours | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | DT1 MF MM | DT1 MF | Total |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 9.47 | 36.1 years STANDARD_DEVIATION 10.07 | 36.2 years STANDARD_DEVIATION 9.71 |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 87 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 87 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Incidence of Ocular Discomfort Device-related Adverse Events (AE)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as Related to study device and deemed to be related to ocular discomfort.
Time frame: Day 1 at Hour 9
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DT1 MF MM | Incidence of Ocular Discomfort Device-related Adverse Events (AE) | 0 Events |
| DT1 MF | Incidence of Ocular Discomfort Device-related Adverse Events (AE) | 1 Events |
Secondary
Limbal Hyperemia
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
Time frame: Day 1 at Hour 9
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| DT1 MF MM | Limbal Hyperemia | Grade 1 | 20 Eyes |
| DT1 MF MM | Limbal Hyperemia | Grade 3 | 0 Eyes |
| DT1 MF MM | Limbal Hyperemia | Grade 2 | 0 Eyes |
| DT1 MF MM | Limbal Hyperemia | Grade 4 | 0 Eyes |
| DT1 MF MM | Limbal Hyperemia | Grade 0 | 60 Eyes |
| DT1 MF | Limbal Hyperemia | Grade 4 | 0 Eyes |
| DT1 MF | Limbal Hyperemia | Grade 0 | 52 Eyes |
| DT1 MF | Limbal Hyperemia | Grade 1 | 27 Eyes |
| DT1 MF | Limbal Hyperemia | Grade 2 | 1 Eyes |
| DT1 MF | Limbal Hyperemia | Grade 3 | 0 Eyes |
Secondary
Ocular Staining
Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Time frame: Day 1 at Hour 9
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| DT1 MF MM | Ocular Staining | Conjunctival Staining, Grade 1 | 15 Eyes |
| DT1 MF MM | Ocular Staining | Limbal Staining, Grade 2 | 1 Eyes |
| DT1 MF MM | Ocular Staining | Conjunctival Staining, Grade 2 | 5 Eyes |
| DT1 MF MM | Ocular Staining | Corneal Staining, Grade 3 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Conjunctival Staining, Grade 3 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Corneal Staining, Grade 1 | 14 Eyes |
| DT1 MF MM | Ocular Staining | Conjunctival Staining, Grade 4 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Corneal Staining, Grade 4 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Limbal Staining, Grade 0 | 72 Eyes |
| DT1 MF MM | Ocular Staining | Corneal Staining, Grade 0 | 62 Eyes |
| DT1 MF MM | Ocular Staining | Limbal Staining, Grade 1 | 7 Eyes |
| DT1 MF MM | Ocular Staining | Limbal Staining, Grade 3 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Conjunctival Staining, Grade 0 | 60 Eyes |
| DT1 MF MM | Ocular Staining | Limbal Staining, Grade 4 | 0 Eyes |
| DT1 MF MM | Ocular Staining | Corneal Staining, Grade 2 | 4 Eyes |
| DT1 MF | Ocular Staining | Limbal Staining, Grade 4 | 0 Eyes |
| DT1 MF | Ocular Staining | Limbal Staining, Grade 2 | 0 Eyes |
| DT1 MF | Ocular Staining | Corneal Staining, Grade 0 | 63 Eyes |
| DT1 MF | Ocular Staining | Corneal Staining, Grade 1 | 17 Eyes |
| DT1 MF | Ocular Staining | Corneal Staining, Grade 2 | 0 Eyes |
| DT1 MF | Ocular Staining | Corneal Staining, Grade 3 | 0 Eyes |
| DT1 MF | Ocular Staining | Corneal Staining, Grade 4 | 0 Eyes |
| DT1 MF | Ocular Staining | Conjunctival Staining, Grade 0 | 61 Eyes |
| DT1 MF | Ocular Staining | Conjunctival Staining, Grade 1 | 15 Eyes |
| DT1 MF | Ocular Staining | Conjunctival Staining, Grade 2 | 4 Eyes |
| DT1 MF | Ocular Staining | Conjunctival Staining, Grade 3 | 0 Eyes |
| DT1 MF | Ocular Staining | Conjunctival Staining, Grade 4 | 0 Eyes |
| DT1 MF | Ocular Staining | Limbal Staining, Grade 0 | 67 Eyes |
| DT1 MF | Ocular Staining | Limbal Staining, Grade 3 | 0 Eyes |
| DT1 MF | Ocular Staining | Limbal Staining, Grade 1 | 13 Eyes |