Back to resultsOne-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Test solution
Control solution
Sponsored by
About this trial
This is an interventional other trial for Myopia focused on measuring Multipurpose Contact Lens Care System
Eligibility Criteria
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.
Sites / Locations
- Golden Vision
- Kannarr Eye Care
- Sacco Eye Group
- Optometry Group PLLC
- Frazier Vision, Inc.
- Eyesite
- Leightons and Tempany
- Brock and Houlford
- Harrold Opticians
- First Contact
- Visioncare Research Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test solution
Control solution
Arm Description
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.
Outcomes
Primary Outcome Measures
Comfort
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
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.
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)
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)
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.
Limbal Hyperemia
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Bulbar Hyperemia
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Secondary Outcome Measures
Full Information
NCT ID
NCT03278223
First Posted
September 8, 2017
Last Updated
March 2, 2021
Sponsor
OTE North America
Collaborators
Visioncare Research Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03278223
Brief Title
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Official Title
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OTE North America
Collaborators
Visioncare Research Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
Keywords
Multipurpose Contact Lens Care System
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test solution
Arm Type
Active Comparator
Arm Description
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
Arm Title
Control solution
Arm Type
Active Comparator
Arm Description
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
Intervention Type
Device
Intervention Name(s)
Test solution
Intervention Description
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
Intervention Type
Device
Intervention Name(s)
Control solution
Intervention Description
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
Primary Outcome Measure Information:
Title
Comfort
Description
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
Title
Visual Acuity (VA)
Description
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.
Title
Lens Surface Wetting
Description
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
Title
Film Deposits
Description
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
Title
Corneal Staining
Description
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.
Time Frame
Up to 4 weeks
Title
Limbal Hyperemia
Description
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Time Frame
Up to 4 weeks
Title
Bulbar Hyperemia
Description
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances L Nicklin, Bsc, MCOptom
Organizational Affiliation
Visioncare Research Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Optometry Group PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Frazier Vision, Inc.
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Eyesite
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 1EX
Country
United Kingdom
Facility Name
Leightons and Tempany
City
Poole
State/Province
Bournemouth
ZIP/Postal Code
BH15 1AU
Country
United Kingdom
Facility Name
Brock and Houlford
City
Chew Magna
State/Province
Bristol
ZIP/Postal Code
BS40 8PR
Country
United Kingdom
Facility Name
Harrold Opticians
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
UB8 1JX
Country
United Kingdom
Facility Name
First Contact
City
Eastcote
State/Province
Pinner
ZIP/Postal Code
HA5 1RJ
Country
United Kingdom
Facility Name
Visioncare Research Ltd
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
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