An interventional study of Test solution and Control solution in Myopia and Hyperopia, sponsored by OTE North America. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by OTE North America · Not applicable, Interventional, and Other
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.
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:
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
Device: Test solution
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
Device: Control solution
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.
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
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.
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
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
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
Limbal Hyperemia
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Time frame: Up to 4 weeks
Bulbar Hyperemia
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Time frame: Up to 4 weeks
| Milestone | Test Solution | Control Solution |
|---|---|---|
| Started | 125 | 69 |
| Completed | 122 | 65 |
| Not completed | 3 | 4 |
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
| score on a scale | Test Solution | Control Solution |
|---|---|---|
| Comfort | 8.44 ± 0.31 | 8.11 ± 0.33 |
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.
| units on a scale | Test Solution | Control Solution |
|---|---|---|
| Visual Acuity (VA) | -0.02 ± 0.01 | -0.02 ± 0.01 |
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)
| units on a scale | Test Solution | Control Solution |
|---|---|---|
| Lens Surface Wetting | 3.33 ± 0.17 | 3.28 ± 0.17 |
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)
| units on a scale | Test Solution | Control Solution |
|---|---|---|
| Film Deposits | 0.37 ± 0.12 | 0.57 ± 0.13 |
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.
| score on a scale | Test Solution | Control Solution |
|---|---|---|
| Corneal Staining | 0.10 ± 0.04 | 0.27 ± 0.05 |
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
| units on a scale | Test Solution | Control Solution |
|---|---|---|
| Limbal Hyperemia | 0.43 ± 0.12 | 0.44 ± 0.12 |
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
| units on a scale | Test Solution | Control Solution |
|---|---|---|
| Bulbar Hyperemia | 0.55 ± 0.14 | 0.55 ± 0.14 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Solution | 0/125 (0%) | 0/125 (0%) | 4/125 (3.2%) |
| Control Solution | 0/69 (0%) | 0/69 (0%) | 6/69 (8.7%) |
| Event | Test Solution | Control Solution |
|---|---|---|
| Solution induced Corneal stainingEye disorders | 0/125 | 2/69 |
| Viral Stomach BugGastrointestinal disorders | 0/125 | 1/69 |
| Solution reactionEye disorders | 0/125 | 1/69 |
| Left eye sore and painfulEye disorders | 0/125 | 1/69 |
| Possible reaction to material or solution.Eye disorders | 0/125 | 1/69 |
| AnxietyGeneral disorders | 1/125 | 0/69 |
| Ocular BurningEye disorders | 1/125 | 0/69 |
| Solution reactionEye disorders | 1/125 | 0/69 |
| Symptoms requiring action, (a piece of contact lens (foreign body) removedEye disorders | 1/125 | 0/69 |
| Age, Categorical(Participants) | Test Solution | Control Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 125 | 66 | 191 |
| >=65 years | 0 | 3 | 3 |
| Sex: Female, Male(Participants) | Test Solution | Control Solution | Total |
|---|---|---|---|
| Female | 89 | 50 | 139 |
| Male | 36 | 19 | 55 |
| Race and Ethnicity Not Collected(Participants) | Test Solution | Control Solution | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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