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Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear

Not Applicable
Completed
Conditions
Refractive Errors
Registration Number
NCT03560141
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.

Detailed Description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria
  • Able to understand and sign an approved Informed Consent form.
  • Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality.
  • Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria
  • Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
  • Current Biofinity® lens wearer.
  • Pregnant or breast-feeding.
  • Other protocol-specified exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Visual Acuity (VA) With Study Lenses, Collected by EyeDay 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit

Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Alcon Investigative Site

🇺🇸

Johns Creek, Georgia, United States

Alcon Investigative Site
🇺🇸Johns Creek, Georgia, United States

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