One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

Completed · Not applicable

Conditions studied: Myopia, Hyperopia

In brief

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.

Key facts

Study ID

NCT03278223

Run by

OTE North America

People needed

194

Starts

2017-08-14

Expected to finish

2017-12-20

Last updated by the study team

2021-03-26

Who can join

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

You may qualify if…

• Be a currently adapted soft contact lens wearer (>1 month of lens wear).
• Be at least 18 years of age.
• Refractive astigmatism <0.75 D in both eyes.
• Have clear corneas and be free of any anterior segment disorders.
• Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or better in each eye.
• Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).
• Require visual correction in both eyes (monovision allowed, no monofit).
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia
• No strabismus
• No evidence of lid abnormality or infection
• No conjunctival abnormality or infection that would contraindicate contact lens wear
• No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
• No other active ocular disease.

You may not qualify if…

• Require toric or multifocal contact lenses.
• Previously shown a sensitivity to any of the study solution components.
• Any systemic or ocular disease or allergies affecting ocular health.
• Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
• Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
• Keratoconus or other corneal irregularity.
• Aphakia or amblyopia.
• Have undergone corneal refractive surgery or any anterior segment surgery.
• Abnormal lacrimal secretions.
• Has diabetes.
• Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• History of chronic eye disease (e.g. glaucoma).
• Pregnant or lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 30 days.

Where it is running

• Golden Vision — Sarasota, Florida, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Sacco Eye Group — Vestal, New York, United States
• 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
• Visioncare Research Ltd — Farnham, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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