- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03278223
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
March 2, 2021 updated by: OTE North America
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.
Study Overview
Status
Completed
Intervention / Treatment
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 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
Enrollment (Actual)
194
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berkshire
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Reading, Berkshire, United Kingdom, RG1 1EX
- Eyesite
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Bournemouth
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Poole, Bournemouth, United Kingdom, BH15 1AU
- Leightons and Tempany
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Bristol
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Chew Magna, Bristol, United Kingdom, BS40 8PR
- Brock and Houlford
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Middlesex
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Uxbridge, Middlesex, United Kingdom, UB8 1JX
- Harrold Opticians
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Pinner
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Eastcote, Pinner, United Kingdom, HA5 1RJ
- First Contact
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Surrey
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Farnham, Surrey, United Kingdom, GU9 7EN
- Visioncare Research Ltd
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Florida
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Sarasota, Florida, United States, 34232
- Golden Vision
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Kansas
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Pittsburg, Kansas, United States, 66762
- Kannarr Eye Care
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New York
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Vestal, New York, United States, 13850
- Sacco Eye Group
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Tennessee
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Memphis, Tennessee, United States, 38111
- Optometry Group Pllc
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Texas
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Tyler, Texas, United States, 75703
- Frazier Vision, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Test solution
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
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A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
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Active Comparator: Control solution
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
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A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort
Time Frame: Up to 4 weeks
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Subjective comfort(during the day).
Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
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Up to 4 weeks
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Visual Acuity (VA)
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.
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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.
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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.
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Lens Surface Wetting
Time Frame: Up to 4 weeks
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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)
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Up to 4 weeks
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Film Deposits
Time Frame: Up to 4 weeks
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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)
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Up to 4 weeks
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Corneal Staining
Time Frame: Up to 4 weeks
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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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Up to 4 weeks
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Limbal Hyperemia
Time Frame: Up to 4 weeks
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Assessed using slit lamp with white light, low-medium magnification.
0-4 ( 4= Severe)
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Up to 4 weeks
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Bulbar Hyperemia
Time Frame: Up to 4 weeks
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Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
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Up to 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frances L Nicklin, Bsc, MCOptom, Visioncare Research Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2017
Primary Completion (Actual)
November 17, 2017
Study Completion (Actual)
December 20, 2017
Study Registration Dates
First Submitted
September 8, 2017
First Submitted That Met QC Criteria
September 8, 2017
First Posted (Actual)
September 11, 2017
Study Record Updates
Last Update Posted (Actual)
March 26, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OTES-3301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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