The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
194
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
Golden Vision
Sarasota, Florida, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Sacco Eye Group
Vestal, New York, United States
Comfort
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Time frame: Up to 4 weeks
Visual Acuity (VA)
Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.
Time frame: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
Lens Surface Wetting
Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)
Time frame: Up to 4 weeks
Film Deposits
Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)
Time frame: Up to 4 weeks
Corneal Staining
Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.
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Optometry Group PLLC
Memphis, Tennessee, United States
Frazier Vision, Inc.
Tyler, Texas, United States
Eyesite
Reading, Berkshire, United Kingdom
Leightons and Tempany
Poole, Bournemouth, United Kingdom
Brock and Houlford
Chew Magna, Bristol, United Kingdom
Harrold Opticians
Uxbridge, Middlesex, United Kingdom
First Contact
Eastcote, Pinner, United Kingdom
...and 1 more locations
Time frame: Up to 4 weeks
Limbal Hyperemia
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Time frame: Up to 4 weeks
Bulbar Hyperemia
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Time frame: Up to 4 weeks