Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
Senofilcon A; Comfilcon A
+ Comfilcon A; Senofilcon A
+ Senofilcon A; Comfilcon A
Eye Diseases
+ Refractive Errors
+ Myopia
Other Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other 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.Over 18 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: Subjects must satisfy the following conditions prior to inclusion in the study: Has had an oculo-visual examination in the last two years Is at least 18 years of age and has full legal capacity to volunteer Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction Currently wears soft contact lenses at least 3 days a week, 8 hours a day Has clear corneas and no active ocular disease Has not worn lenses for at least 12 hours before the examination Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes) No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection). No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology) No aphakia Has prescription to match the available power range. Exclusion Criteria: Any of the following will render a subject ineligible for inclusion: Greater than 0.75 of refractive astigmatism in either eye Has never worn contact lenses before Wears contact lenses on an extended wear basis Has any systemic disease affecting ocular health Is a known sufferer of ocular allergies Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities Is aphakic Has undergone corneal refractive surgery. Is wearing monovision Is participating in any other type of clinical or research study Female who is currently pregnant or is breast-feeding Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary 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 1 location
University of Houston College of Optometry, TERTC
Houston, United StatesOpen University of Houston College of Optometry, TERTC in Google Maps