Mode
Text Size
Log in / Sign up
N/A Completed N=45 Randomized Double-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search