One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

• Sponsor: OTE North America (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03278223
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 194
• Locations: 11
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site: 17.6
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: Test solution; Device: Control solution	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
• Actual Study Start Date: Aug 14, 2017
• Actual Primary Completion Date: Nov 17, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test solution 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-2.
Active Comparator: Control 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-1.

Outcome Measures

Primary Outcome Measures

1. 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.)

2. 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.

3. 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)

4. 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)

5. 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.

6. Limbal Hyperemia [Up to 4 weeks]

   Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)

7. Bulbar Hyperemia [Up to 4 weeks]

   Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Golden Vision	Sarasota	Florida	United States	34232
2	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
3	Sacco Eye Group	Vestal	New York	United States	13850
4	Optometry Group PLLC	Memphis	Tennessee	United States	38111
5	Frazier Vision, Inc.	Tyler	Texas	United States	75703
6	Eyesite	Reading	Berkshire	United Kingdom	RG1 1EX
7	Leightons and Tempany	Poole	Bournemouth	United Kingdom	BH15 1AU
8	Brock and Houlford	Chew Magna	Bristol	United Kingdom	BS40 8PR
9	Harrold Opticians	Uxbridge	Middlesex	United Kingdom	UB8 1JX
10	First Contact	Eastcote	Pinner	United Kingdom	HA5 1RJ
11	Visioncare Research Ltd	Farnham	Surrey	United Kingdom	GU9 7EN

Sponsors and Collaborators

• OTE North America
• Visioncare Research Ltd.

Investigators

• Principal Investigator: Frances L Nicklin, Bsc, MCOptom, Visioncare Research Ltd.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 10, 2017
• Informed Consent Form - Jul 27, 2017

More Information

Publications

None provided.

• Responsible Party: OTE North America
• ClinicalTrials.gov Identifier: NCT03278223
• Other Study ID Numbers: OTES-3301
• First Posted: Sep 11, 2017
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by OTE North America: Multipurpose Contact Lens Care System
• Additional relevant MeSH terms: Hyperopia; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	Test Solution	Control Solution
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	125	69
COMPLETED	122	65
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Test Solution	Control Solution	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	125	69	194
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	125 100%	66 95.7%	191 98.5%
>=65 years	0 0%	3 4.3%	3 1.5%
Sex: Female, Male (Count of Participants)
Female	89 71.2%	50 72.5%	139 71.6%
Male	36 28.8%	19 27.5%	55 28.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [score on a scale]	8.44 (0.31)	8.11 (0.33)

2. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [units on a scale]	-0.02 (0.01)	-0.02 (0.01)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [units on a scale]	3.33 (0.17)	3.28 (0.17)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [units on a scale]	0.37 (0.12)	0.57 (0.13)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [score on a scale]	0.10 (0.04)	0.27 (0.05)

6. Primary Outcome

Title	Limbal Hyperemia
Description	Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [units on a scale]	0.43 (0.12)	0.44 (0.12)

7. Primary Outcome

Title	Bulbar Hyperemia
Description	Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Solution	Control Solution
Arm/Group 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.
Measure Participants	122	65
Least Squares Mean (Standard Error) [units on a scale]	0.55 (0.14)	0.55 (0.14)

Adverse Events

Time Frame	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.
Arm/Group Title	Test Solution		Control Solution
Arm/Group Description	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.
All Cause Mortality
	Test Solution		Control Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/69 (0%)
Serious Adverse Events
	Test Solution		Control Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	Test Solution		Control Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/125 (3.2%)		6/69 (8.7%)
Eye disorders
Ocular Burning	1/125 (0.8%)	1	0/69 (0%)	0
Solution reaction	0/125 (0%)	0	1/69 (1.4%)	1
Solution reaction	1/125 (0.8%)	1	0/69 (0%)	0
Solution induced Corneal staining	0/125 (0%)	0	2/69 (2.9%)	2
Left eye sore and painful	0/125 (0%)	0	1/69 (1.4%)	1
Symptoms requiring action, (a piece of contact lens (foreign body) removed	1/125 (0.8%)	1	0/69 (0%)	0
Possible reaction to material or solution.	0/125 (0%)	0	1/69 (1.4%)	1
Gastrointestinal disorders
Viral Stomach Bug	0/125 (0%)	0	1/69 (1.4%)	1
General disorders
Anxiety	1/125 (0.8%)	1	0/69 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.