N/A
Completed N=14
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Source: ClinicalTrials.gov NCT02719353 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Visual Acuity — -0.01; -0.07; -0.15; -0.13 LogMAR
Summary
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.01; -0.07; -0.15; -0.13; -0.02; 0.01 | — |
| PRIMARY Visual Performance |
72; 77; 85; 88; 79; 80 | — |
| SECONDARY Subjective Ratings for Comfort |
87; 89 | — |
| SECONDARY Subjective Ratings for Dryness |
83; 88 | — |
| SECONDARY Lens Handling |
89; 95 | — |
| SECONDARY Average Daily Wearing Time |
10; 9 | — |
| SECONDARY Lens Fit |
3.3; 3.3 | — |
| SECONDARY Bulbar Hyperemia |
0.88; 0.89 | — |
| SECONDARY Limbal Hyperemia |
0.13; 0.18 | — |
| SECONDARY Subjective Satisfaction |
71; 74 | — |
| SECONDARY Subjective Preference for Near Vision |
4; 4; 5 | — |
| SECONDARY Subjective Preference for Distance Vision |
3; 2; 8 | — |
| SECONDARY Subjective Preference for Intermediate Vision |
3; 4; 6 | — |
| SECONDARY Subjective Preference for Overall Vision |
3; 1; 9 | — |
| SECONDARY Subjective Preference for Comfort |
4; 3; 6 | — |
| SECONDARY Subjective Overall Lens Preference |
4; 0; 9 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Has had a self-reported oculo-visual examination in the last two years
- Is 50 years of age or greater and has full legal capacity to volunteer
- Is able to read and understand the informed consent
- Is willing and able to follow instructions and maintain the appointment schedule
- Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
- Near Add Power requirement of +2.25D or greater
- Has spectacle cylinder 0.75 D in both eyes
- Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
- Has clear corneas and no active ocular disease
- Has not worn gas permeable contact lenses for 1 month prior to the study
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or abnormality that would affect the wearing of contact lenses
- Is aphakic (i.e. missing their natural lens inside their eye)
- Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
- Has undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02719353). 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. Informational only — not medical advice.