Presbyopia
Conditions
Brief summary
The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.
Detailed description
This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.
Interventions
DEVICEControl Lenses (control fitting approach)
Daily wear multifocal lenses for 1 week
DEVICETest Lenses (test fitting approach)
Daily wear multifocal lenses for 1 week
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 40 years old; * Have read and understood the Participant Information Sheet; * Have read, signed and dated the Informed Consent; * Best corrected visual acuity of at least 20/25 in each eye; * Have normal eyes with the exception of the need for visual correction; * Current multifocal contact lens wearer; * Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D * Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
Exclusion criteria
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * Monocular participants (only one eye with functional vision) or participants fit with only one lens; * Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit; * History of herpetic keratitis, ocular surgery or irregular cornea; * Known pregnancy or lactation during the study period; * Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision Satisfaction | One week | Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied |
| Overall Lens Preference | Two weeks | Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Binocular Visual Acuity Index | One week | Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities |
| Number of Contact Lenses | One week | This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Twenty-five participants were screened and subsequently enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population Includes all study participants. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Overall Study Population | — |
|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 2.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Overall Lens Preference
Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'
Time frame: Two weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Lenses | Overall Lens Preference | Control Lenses | 10 Participants |
| Control Lenses | Overall Lens Preference | Test Lenses | 11 Participants |
| Control Lenses | Overall Lens Preference | No Preference | 4 Participants |
Primary
Overall Vision Satisfaction
Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lenses | Overall Vision Satisfaction | 78.6 score on a scale | Standard Deviation 18.3 |
| Test Lenses | Overall Vision Satisfaction | 83.5 score on a scale | Standard Deviation 14.9 |
Secondary
Number of Contact Lenses
This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lenses | Number of Contact Lenses | 1 number of contact lenses (pair) | Standard Error 0 |
| Test Lenses | Number of Contact Lenses | 1 number of contact lenses (pair) | Standard Error 0 |
Secondary
Overall Binocular Visual Acuity Index
Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lenses | Overall Binocular Visual Acuity Index | 0.12 logMAR | Standard Deviation 0.04 |
| Test Lenses | Overall Binocular Visual Acuity Index | 0.09 logMAR | Standard Deviation 0.05 |