Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
Test lens
+ control lens
Eye Diseases
+ Myopia
+ Refractive Errors
Treatment Study
Summary
Study start date: April 18, 2018
Actual date on which the first participant was enrolled.This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.77 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 35 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Golden Optometric Group
Whittier, United StatesGolden Vision
Sarasota, United StatesNittany Eye Associates
State College, United States