Hyperopia, Myopia
Conditions
Keywords
Multipurpose Contact Lens Care System
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.
Interventions
DEVICETest solution
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
DEVICEControl solution
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
Sponsors
Visioncare Research Ltd.
OTE North America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: 1. No amblyopia 2. No strabismus 3. No evidence of lid abnormality or infection 4. No conjunctival abnormality or infection that would contraindicate contact lens wear 5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities) 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Up to 4 weeks | 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) | 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. | 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 | Up to 4 weeks | 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 | Up to 4 weeks | 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 | Up to 4 weeks | 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 | Up to 4 weeks | Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe) |
| Bulbar Hyperemia | Up to 4 weeks | Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe) |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 125 |
| 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. | 69 |
| Total | 194 |
Baseline characteristics
| Characteristic | Test Solution | Control Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 66 Participants | 191 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 89 Participants | 50 Participants | 139 Participants |
| Sex: Female, Male Male | 36 Participants | 19 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 69 |
| other Total, other adverse events | 4 / 125 | 6 / 69 |
| serious Total, serious adverse events | 0 / 125 | 0 / 69 |
Outcome results
Primary
Bulbar Hyperemia
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Time frame: Up to 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Bulbar Hyperemia | 0.55 units on a scale | Standard Error 0.14 |
| Control Solution | Bulbar Hyperemia | 0.55 units on a scale | Standard Error 0.14 |
Primary
Comfort
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Comfort | 8.44 score on a scale | Standard Error 0.31 |
| Control Solution | Comfort | 8.11 score on a scale | Standard Error 0.33 |
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.
Time frame: Up to 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Corneal Staining | 0.10 score on a scale | Standard Error 0.04 |
| Control Solution | Corneal Staining | 0.27 score on a scale | Standard Error 0.05 |
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)
Time frame: Up to 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Film Deposits | 0.37 units on a scale | Standard Error 0.12 |
| Control Solution | Film Deposits | 0.57 units on a scale | Standard Error 0.13 |
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)
Time frame: Up to 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Lens Surface Wetting | 3.33 units on a scale | Standard Error 0.17 |
| Control Solution | Lens Surface Wetting | 3.28 units on a scale | Standard Error 0.17 |
Primary
Limbal Hyperemia
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Time frame: Up to 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Limbal Hyperemia | 0.43 units on a scale | Standard Error 0.12 |
| Control Solution | Limbal Hyperemia | 0.44 units on a scale | Standard Error 0.12 |
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.
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Solution | Visual Acuity (VA) | -0.02 units on a scale | Standard Error 0.01 |
| Control Solution | Visual Acuity (VA) | -0.02 units on a scale | Standard Error 0.01 |