N/A
Completed N=17
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Source: ClinicalTrials.gov NCT03417557 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Visual Acuity — -0.01; -0.03; -0.05; 0.06 logMAR
Summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.01; -0.03; -0.05; 0.06; 0.02; 0.13 | — |
| SECONDARY Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity |
91; 79 | — |
| SECONDARY Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity |
87; 82 | — |
| SECONDARY Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity |
84; 79 | — |
Eligibility Criteria
Inclusion Criteria
- Has had a self-reported oculo-visual examination in the last two years.
- Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
- Is able to participate in Parts A and B related to this work.
- Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT03417557). 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.