N/A
Completed N=45
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
Source: ClinicalTrials.gov NCT03306641 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Lens Fit Acceptance — 2.6; 3.1 units on a scale
Summary
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit Acceptance |
2.6; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years of age and has full legal capacity to volunteer.
- Is no greater than 55 years of age.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
- Has spectacle cylinder ≤1.00D in both eyes.
- Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
- Wears CLs in both eyes (monvision acceptable, but not monofit)
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion Criteria
- 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 strabismus/amblyopia.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating or planning a pregnancy.
- Is participating in any concurrent clinical or research study.
Data sourced from ClinicalTrials.gov (NCT03306641). 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.