Mode
Text Size
Log in / Sign up
N/A N=77 Treatment

Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

Myopia

Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Overall Lens Fit Acceptance — 3.90; 3.81 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Test lens (Device); control lens (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Lens Fit Acceptance
3.79; 3.83
PRIMARY
Overall Lens Fit Acceptance
3.79; 3.83
SECONDARY
Lens Centration
75; 76; 2; 1; 0; 0
SECONDARY
Lens Centration
75; 76; 2; 1; 0; 0
SECONDARY
Post-blink Movement
1.92; 1.96
SECONDARY
Post-blink Movement
1.92; 1.96

Summary

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 35 years of age (inclusive)
  • Has read and signed the informed consent letter
  • Is willing and anticipated to follow instructions and maintain the appointment schedule
  • Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
  • Habitually wears or is able to be adequately refit into MyDay Sphere lenses
  • Demonstrates an acceptable fit with the study lenses
  • Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
  • Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
  • Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
  • Has clear corneas and no active ocular disease
  • Has a contact lens refraction that fits within the available parameters of the study lenses.

Exclusion Criteria

A person will be excluded from the study if he/she:

  • Is participating in any concurrent clinical research study
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a systemic condition that, in the opinion of the investigator, may affect the study measures
  • Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
  • Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone refractive surgery.
  • Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
  • Has participated in any other type of eye related clinical or research study within the last 7 days
  • Is habitually using rewetting/ lubricating eye drops (more than once per day)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03496701). 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.

Back to search