Status:
COMPLETED
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Lead Sponsor:
OTE North America
Collaborating Sponsors:
Visioncare Research Ltd.
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 u...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03278223
Start Date
August 14 2017
End Date
December 20 2017
Last Update
March 26 2021
Active Locations (11)
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1
Golden Vision
Sarasota, Florida, United States, 34232
2
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
3
Sacco Eye Group
Vestal, New York, United States, 13850
4
Optometry Group PLLC
Memphis, Tennessee, United States, 38111