Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
delefilcon A
+ etafilcon A
+ delefilcon A
Eye Diseases
+ Refractive Errors
+ Myopia
Other Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.183 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.From 18 to 45 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: The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF). The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week. The subject must be a current successful soft contact lens wearer in both eyes The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye. The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes. The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. The subject must require a visual correction in both eyes (no monofit or monovision allowed). The subject must 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 (including blepharitis/meibomitis). No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation. No extended wear in the last 3 months. Diabetes. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV). Employee or family member of the staff of the investigational site.
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
ExperimentalGroup II
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 10 locations