Trial Outcomes & Findings for One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System (NCT NCT03278223)
NCT ID: NCT03278223
Last Updated: 2021-03-26
Results Overview
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
194 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2021-03-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
69
|
|
Overall Study
COMPLETED
|
122
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Solution
n=125 Participants
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.
|
Control Solution
n=69 Participants
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.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=125 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=194 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=125 Participants
|
66 Participants
n=69 Participants
|
191 Participants
n=194 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=125 Participants
|
3 Participants
n=69 Participants
|
3 Participants
n=194 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=125 Participants
|
50 Participants
n=69 Participants
|
139 Participants
n=194 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=125 Participants
|
19 Participants
n=69 Participants
|
55 Participants
n=194 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 4 weeksSubjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Comfort
|
8.44 score on a scale
Standard Error 0.31
|
8.11 score on a scale
Standard Error 0.33
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Visual Acuity (VA)
|
-0.02 units on a scale
Standard Error 0.01
|
-0.02 units on a scale
Standard Error 0.01
|
PRIMARY outcome
Timeframe: Up to 4 weeksLens 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)
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Lens Surface Wetting
|
3.33 units on a scale
Standard Error 0.17
|
3.28 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Up to 4 weeksAny 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)
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Film Deposits
|
0.37 units on a scale
Standard Error 0.12
|
0.57 units on a scale
Standard Error 0.13
|
PRIMARY outcome
Timeframe: Up to 4 weeksAssessed 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.
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Corneal Staining
|
0.10 score on a scale
Standard Error 0.04
|
0.27 score on a scale
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Up to 4 weeksAssessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Limbal Hyperemia
|
0.43 units on a scale
Standard Error 0.12
|
0.44 units on a scale
Standard Error 0.12
|
PRIMARY outcome
Timeframe: Up to 4 weeksAssessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Outcome measures
| Measure |
Test Solution
n=122 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=65 Participants
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
Bulbar Hyperemia
|
0.55 units on a scale
Standard Error 0.14
|
0.55 units on a scale
Standard Error 0.14
|
Adverse Events
Test Solution
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Solution
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Solution
n=125 participants at risk
Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
|
Control Solution
n=69 participants at risk
Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
|
|---|---|---|
|
General disorders
Anxiety
|
0.80%
1/125 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Eye disorders
Ocular Burning
|
0.80%
1/125 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Gastrointestinal disorders
Viral Stomach Bug
|
0.00%
0/125 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
|
Eye disorders
Solution reaction
|
0.80%
1/125 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Eye disorders
Solution induced Corneal staining
|
0.00%
0/125 • 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.
|
2.9%
2/69 • Number of events 2 • 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.
|
|
Eye disorders
Left eye sore and painful
|
0.00%
0/125 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
|
Eye disorders
Symptoms requiring action, (a piece of contact lens (foreign body) removed
|
0.80%
1/125 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Eye disorders
Possible reaction to material or solution.
|
0.00%
0/125 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
Additional Information
Mr Thomas Boyes, Clinical Project Manager
Visioncare Research Ltd.
Phone: +441252 718719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER