Completed

Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

delefilcon A

+ etafilcon A

+ delefilcon A

Device
Who is being recruted

Eye Diseases

+ Refractive Errors

+ Myopia

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: August 2012
See protocol details

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: 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.

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

183 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



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 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

Eye DiseasesRefractive ErrorsMyopia

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear

Group II

Experimental
6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

Study 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

Little Rock, United StatesOpen in Google Maps

Bridgeport, United States

Tampa, United States

Blue Springs, United States
Completed10 Study Centers