Completed
Contact Lens Comfort Relative to Meibomian Gland Status
What is being tested
senofilcon A
Device
Who is being recruted
Eye Diseases
+ Eyelid Diseases
+ Meibomian Gland Dysfunction
From 18 to 39 Years
+28 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: March 2013
Summary
Principal SponsorJohnson & Johnson Vision Care, Inc.
Last updated: June 19, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
Principal SponsorJohnson & Johnson Vision Care, Inc.
Last updated: June 19, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 39 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesEyelid DiseasesMeibomian Gland Dysfunction
Criteria
9 inclusion criteria required to participate
Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week)
The subject be able and willing to adhere to the instructions set forth in this clinical protocol
The subject must be 18 and less than 39 years of age
The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form
Show More Criteria
19 exclusion criteria prevent from participating
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear
Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report)
Any ocular or systemic allergies or diseases that may interfere with contact lens wear
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAcuvvue Oasys with Hydaclear Plus with 38% water.
Study 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
Fullerton, United StatesOpen in Google Maps
CompletedOne Study Center