Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study

Completed · Not applicable

Conditions studied: Corneal Disease, Hypersensitivity

In brief

The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied: * within the corresponding range of lens powers * in a population randomized within multiple investigational sites * with a study ration of 2/1 test vs control lenses * for a duration of 90 days.

Key facts

Study ID

NCT00804505

Run by

SynergEyes, Inc.

People needed

98

Starts

2008-06-01

Expected to finish

2008-12-01

Last updated by the study team

2009-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Have
• read the Informed Consent,
• been given an explanation of the Informed Consent,
• indicated an understanding of the Informed Consent and
• signed the Informed Consent Form.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be a current contact lens wearer.
• Possess wearable and visually functional eyeglasses.
• Be in good general health, based on his/her knowledge.
• Require spectacle lens powers between plano and -6.00 diopters sphere with no more than -2.50 diopters of spectacle refractive astigmatism and be willing to wear lenses in both eyes.
• Have manifest refraction visual acuity equal to or better than 20/25 in each eye.

You may not qualify if…

• Subjects may not be enrolled into the study if ANY of the following apply:
• Subject is wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may NOT wear monovision lenses at any time during the study as it will interfere with the distance visual acuity measurement.
• Subject exhibits poor personal hygiene.
• Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
• Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 3 months or is lactating.
• Subject is a member, relative or household member of the office staff, including the investigator(s).
• Subject has a known sensitivity to ingredients used in contact lens care products or over-the-counter lubricants and artificial tears.
• Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment.
• Subject is aphakic or pseudophakic.
• Subject has ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome lupus erythematosus, scleroderma, keratoconus or type II diabetes.
• Use of ocular medications for any reason or systemic medications which might interfere with contact lens wear.
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
• History of corneal ulcer, corneal infiltrates or fungal infections
• Corneal scars within the visual axis
• Pterygium
• Dry eye symptoms with decrease tear levels and punctate staining ≥ Grade 2
• Neovascularization or ghost vessels > 1.5 mm in from the limbus
• Seborrhoeic eczema, seborrhoeic conjunctivitis
• History of papillary conjunctivitis that has interfered with lens wear or a current condition of Grade 2 (Mild) or greater
• Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
• TO BE ELIGIBLE TO BE RANDOMIZED FOR STUDY PRODUCT TRIAL A SUBJECT MUST HAVE ALL OF THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA PRESENT.
• TO BE ELIGIBLE FOR LENS DISPENSING, THE SUBJECT'S STUDY DEVICE CONTACT LENS VISUAL ACUITY MUST BE EQUAL TO OR BETTER THAN 20/30 IN EACH EYE

Where it is running

• Carmel Mountain Vision Care — San Diego, California, United States
• Silicon Valley Eye Physicians — Sunnyvale, California, United States
• Casazza Optometric Group — Andover, Massachusetts, United States
• Vision Care Associates — East Lansing, Michigan, United States
• Western Reserve Vision Care, Inc. — Beachwood, Ohio, United States
• Dr. Karambelas & Associates — Providence, Rhode Island, United States
• Primary Eyecare Group P.C. — Brentwood, Tennessee, United States
• Snowy Range Vision Center — Laramie, Wyoming, United States

Full record on ClinicalTrials.gov

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