Status:
COMPLETED
Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study
Lead Sponsor:
SynergEyes, Inc.
Conditions:
Corneal Disease
Hypersensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
The objective of the study is to compare the SynergEyes SA Hybrid Contact Lens (Test) to the SynergEyes A Hybrid Contact lens (Control) when used in a daily wear regimen on non-diseased eyes for the c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00804505
Start Date
June 1 2008
End Date
December 1 2008
Last Update
December 23 2009
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Carmel Mountain Vision Care
San Diego, California, United States, 92129
2
Silicon Valley Eye Physicians
Sunnyvale, California, United States, 94087
3
Casazza Optometric Group
Andover, Massachusetts, United States, 01810
4
Vision Care Associates
East Lansing, Michigan, United States, 48823