N/A
Completed N=12
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Source: ClinicalTrials.gov NCT02719366 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Visual Acuity — -0.07; -0.05; 0.06; 0.10 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 |
-0.07; -0.05; 0.06; 0.10; 0.09; 0.05 | — |
| PRIMARY Visual Performance |
65; 64; 77; 78; 76; 65 | — |
| SECONDARY Comfort |
82; 80 | — |
| SECONDARY Comfort |
82; 80 | — |
| SECONDARY Dryness |
84; 81 | — |
| SECONDARY Dryness |
84; 81 | — |
| SECONDARY Subjective Preference for Comfort |
4; 2; 6 | — |
| SECONDARY Subjective Satisfaction |
68; 75 | — |
| SECONDARY Subjective Preference for Near Vision |
4; 4; 4 | — |
| SECONDARY Subjective Preference for Intermediate Vision |
5; 5; 2 | — |
| SECONDARY Subjective Preference for Distance Vision |
6; 4; 2 | — |
| SECONDARY Subjective Overall Vision Preference |
6; 4; 2 | — |
| SECONDARY Average Daily Wearing Time |
11; 11 | — |
| SECONDARY Lens Fit |
3.7; 3.8 | — |
| SECONDARY Lens Handling |
90; 88 | — |
| SECONDARY Bulbar Hyperemia |
1.27; 1.09 | — |
| SECONDARY Limbal Hyperemia |
0.93; 0.76 | — |
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 (NCT02719366). 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.