N/A
N=25
Multifocal Contact Lenses Fitting Methods Comparison
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05734846 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Overall Vision Satisfaction — 78.6; 83.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control Lenses (control fitting approach) (Device); Test Lenses (test fitting approach) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Vision Satisfaction |
78.6; 83.5 | — |
| PRIMARY Overall Lens Preference |
10; 11; 4 | — |
| SECONDARY Overall Binocular Visual Acuity Index |
0.12; 0.09 | — |
| SECONDARY Number of Contact Lenses |
1; 1 | — |
Summary
The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05734846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.