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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test solution | Active Comparator | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. |
|
| Control solution | Active Comparator | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test solution | Device | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.) | 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. | 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) | 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) | 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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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances L Nicklin, Bsc, MCOptom | Visioncare Research Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Vision | Sarasota | Florida | 34232 | United States | ||
| Kannarr Eye Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Solution | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. |
| FG001 | Control Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2017 |
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| Control solution | Device | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. |
|
| Up to 4 weeks |
| Limbal Hyperemia | Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe) | Up to 4 weeks |
| Bulbar Hyperemia | Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe) | Up to 4 weeks |
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Optometry Group PLLC | Memphis | Tennessee | 38111 | United States |
| Frazier Vision, Inc. | Tyler | Texas | 75703 | United States |
| Eyesite | Reading | Berkshire | RG1 1EX | United Kingdom |
| Leightons and Tempany | Poole | Bournemouth | BH15 1AU | United Kingdom |
| Brock and Houlford | Chew Magna | Bristol | BS40 8PR | United Kingdom |
| Harrold Opticians | Uxbridge | Middlesex | UB8 1JX | United Kingdom |
| First Contact | Eastcote | Pinner | HA5 1RJ | United Kingdom |
| Visioncare Research Ltd | Farnham | Surrey | GU9 7EN | United Kingdom |
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Solution | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. |
| BG001 | Control Solution | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comfort | Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.) | Posted | Least Squares Mean | Standard Error | score on a scale | Up to 4 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 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. |
| |||||||||||||||||||||||||||||||
| Primary | 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) | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | 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) | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Up to 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Limbal Hyperemia | Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe) | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Bulbar Hyperemia | Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe) | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 4 weeks |
|
|
Subjects participated in the study for a total duration of 30±4 days. Adverse Event data was collected over a period of approximately 12 weeks from the first participant receiving study product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Solution | Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. | 0 | 125 | 0 | 125 | 4 | 125 |
| EG001 | Control Solution | Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. | 0 | 69 | 0 | 69 | 6 | 69 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | General disorders | Systematic Assessment |
| ||
| Ocular Burning | Eye disorders | Systematic Assessment | Subject reported burning upon insertion of Contact Lens (CL) after using solution overnight. Occurred most mornings, self resolved within a couple minutes. |
| |
| Viral Stomach Bug | Gastrointestinal disorders | Systematic Assessment | Puking, Nausea, Fatigue |
| |
| Solution reaction | Eye disorders | Systematic Assessment | Diffuse punctate stain, grade 1. Very superficial. Extent Grade 3 |
| |
| Solution reaction | Eye disorders | Systematic Assessment | After 20 mins wear, lenses clouded over and if subject kept in for another 10 mins, they experienced pain on lower eye lids. Some redness. Pain, cloudiness and redness disappeared after lens removal. Tried on 4 separate days, but same symptom. |
| |
| Solution induced Corneal staining | Eye disorders | Systematic Assessment |
| ||
| Left eye sore and painful | Eye disorders | Systematic Assessment | Left eye sore and painful with Contact Lenses in. Some pain, redness and discharge. No photophobia. |
| |
| Symptoms requiring action, (a piece of contact lens (foreign body) removed | Eye disorders | Systematic Assessment | A piece of contact lens (foreign body) removed from right upper temporal fornix. Sodium fluorescein instilled - no abrasion or other foreign body remaining. No increased hyperaemia, no lid or eye irritation after lens removed. |
| |
| Possible reaction to material or solution. | Eye disorders | Systematic Assessment | Woke up in the middle of the night and the eyes felt dry, itchy, burning sensation. Next morning the eyes were bloodshot, and slight discharge in both eyes. |
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The Investigator shall not disclose to others any information relating to the study without written authorisation from the Sponsor.
All data and discoveries arising out of the Study, patentable or non-patentable, shall be the sole property of the Sponsor or its designated affiliate.
The Investigator shall agree to obtain the Sponsor's written consent before discussing, presenting or publicising any pre-clinical and/or clinical data or impressions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Thomas Boyes, Clinical Project Manager | Visioncare Research Ltd. | +441252 718719 | 223 | t.boyes@visioncare.co.uk |
| Sep 5, 2017 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2017 | Sep 5, 2017 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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|---|---|
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