Completed

Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens

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

enfilcon A

+ galyfilcon A

Device
Who is being recruted

Eye Diseases

+ Refractive Errors

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorCooperVision, Inc.
Last updated: October 5, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.

Principal SponsorCooperVision, Inc.
Last updated: October 5, 2020
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

50 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



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.

Over 18 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 DiseasesRefractive Errors

Criteria

Inclusion Criteria: Prior to being considered eligible to participate in this study, each subject MUST: Be at least 18 years of age as of the date of evaluation for the study. Have read the Informed Consent, been given an explanation of the Informed Consent, indicated understanding of the Informed Consent, signed the Informed Consent document. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily basis for at least 8 hours per day for at least one month prior to participation in the study. Possess wearable and visually functional eyeglasses. Be in good general health, based on his/her knowledge. Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 2.00 diopters of refractive astigmatism and be willing to wear contact lenses in both eyes. Have: manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye. Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye. Exclusion Criteria: Subjects may not be enrolled in this study if any of the following apply: The subject is/has: Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. Poor personal hygiene. Any active participation in another clinical trial within 30 days prior to this study. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the study period. A member, relative or household member of the investigator or of the investigational office staff. Has a known sensitivity to ingredients used in the care products approved for use in the study. Previous refractive surgery; or current or previous orthokeratology treatment. Is aphakic or psuedophakic. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes. The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities. Any; inflammations such as iritis; or any infection or allergic reaction of the eye, lids, or associated structures. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. A history of papillary conjunctivitis that has interfered with contact lens wear. Slit lamp findings that would contraindicate contact lens wear, including but not limited to: Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2, Pterygium, Corneal scars within the visual axis, Neovascularization or ghost vessels > 1.0 mm in from the limbus, Giant papillary conjunctivitis (GPC) of > Grade 1, Anterior uveitis or iritis, Seborrheic eczema, seborrheic conjunctivitis or blepharitis To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present. To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

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
The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

Group II

Active Comparator
The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

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 3 locations

Advanced Eyecare

Pismo Beach, United StatesOpen Advanced Eyecare in Google Maps

Eric M. White, OD, Inc.

San Diego, United States

Vision Care Associates

East Lansing, United States
Completed3 Study Centers