Study of Soft Contact Lens Use With 7 Day Extended Wear
An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen
1 other identifier
interventional
460
1 country
23
Brief Summary
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2006
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedJuly 17, 2020
July 1, 2020
1.7 years
December 27, 2007
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of serious and significant AEs
Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial
1 Year
Secondary Outcomes (1)
Contact Lens Visual Acuity
1 Year
Study Arms (2)
Test Contact Lenses
EXPERIMENTALVISA (comfilcon A) Silicone Hydrogel Soft contact lens
Control Contact Lenses
ACTIVE COMPARATORAcuvue 2 Soft Contact Lens
Interventions
Test device
Eligibility Criteria
You may qualify if:
- Be at least 18 years of age as of the date of evaluation.
- Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
- Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
- Be in good general health, based on his/her knowledge.
- Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Possess wearable and visually functional eyeglasses.
You may not qualify if:
- Previously unsuccessful with contact lens wear.
- Rigid gas permeable contact lens wear within the past 12 months.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
- Aphakia, keratoconus or an irregular cornea.
- A known history of corneal hypoesthesia
- Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
- Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
- Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- History of corneal ulcer, corneal infiltrates or fungal infections.
- Pterygium, pinguecula or corneal scars within the visual axis
- Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)
- Neovascularization or ghost vessels \> 1mm in from the limbus
- Seborrheic eczema, seborrheic conjunctivitis
- History of papillary conjunctivitis greater than Grade 2 (Mild)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
La Mesa Vision Care Center
La Mesa, California, 91941, United States
(Private Practice)
San Diego, California, 92123, United States
Drs. Cook, Reeder and Associates
San Diego, California, 92129, United States
(Private Practice)
Santa Monica, California, 90403, United States
Eye Care Associates, P.C.
Fort Collins, Colorado, 80521, United States
Eola Eyes
Orlando, Florida, 32801, United States
(Private Practice)
Honolulu, Hawaii, 96814, United States
Kato & Shoji Optometrists
Honolulu, Hawaii, 96815, United States
Eye Care Associates of Hawaii
Waipahu, Hawaii, 96797, United States
Davis Eyecare Associates
Oak Lawn, Illinois, 60453, United States
(Private Practice)
Andover, Massachusetts, 01810, United States
Vision Care Associates
East Lansing, Michigan, 48823, United States
The Koetting Associates Inc.
St Louis, Missouri, 63144, United States
Concord Ophthalmological Associates
Concord, New Hampshire, 03301, United States
Place Optical Company Inc
Le Roy, New York, 14482, United States
Quinn Quinn & Associates
Athens, Ohio, 45701, United States
Western Reserve Vision Care
Beachwood, Ohio, 44122, United States
Ohio State University
Columbus, Ohio, 43210, United States
Professional Eye Care Associates
Columbus, Ohio, 43215, United States
Primary Eyecare Group, P.C.
Brentwood, Tennessee, 37027, United States
(Private Practice)
Salt Lake City, Utah, 84106, United States
Twin Lakes Vision
Federal Way, Washington, 98023, United States
Snowy Range Vision Center
Laramie, Wyoming, 82070, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Gleason, OD
FRS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 18, 2008
Study Start
March 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
July 17, 2020
Record last verified: 2020-07