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

NCT03278223 | Completed Results FDA Device

• 1 other identifier: OTES-3301
• Study Type: interventional
• Target: 194
• Locations: 2 countries
• Sites: 11

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.

Conditions

Myopia; Hyperopia

Keywords

Multipurpose Contact Lens Care System

Outcome Measures

Primary Outcomes (7)

• 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.

  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

Study Arms (2)

Test solution

ACTIVE COMPARATOR

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.

Device: Test solution

Control solution

ACTIVE COMPARATOR

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.

Device: Control solution

Interventions

Test solution DEVICE

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.

Test solution

Control solution DEVICE

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.

Control solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• No amblyopia
• No strabismus
• No evidence of lid abnormality or infection
• No conjunctival abnormality or infection that would contraindicate contact lens wear
• No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
• No other active ocular disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OTE North America: lead
• Visioncare Research Ltd.: collaborator

Study Sites (11)

Golden Vision

Sarasota, Florida, 34232, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Optometry Group PLLC

Memphis, Tennessee, 38111, United States

Location

Frazier Vision, Inc.

Tyler, Texas, 75703, United States

Location

Eyesite

Reading, Berkshire, RG1 1EX, United Kingdom

Location

Leightons and Tempany

Poole, Bournemouth, BH15 1AU, United Kingdom

Location

Brock and Houlford

Chew Magna, Bristol, BS40 8PR, United Kingdom

Location

Harrold Opticians

Uxbridge, Middlesex, UB8 1JX, United Kingdom

Location

First Contact

Eastcote, Pinner, HA5 1RJ, United Kingdom

Location

Visioncare Research Ltd

Farnham, Surrey, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Mr Thomas Boyes, Clinical Project Manager
• Organization: Visioncare Research Ltd.

t.boyes@visioncare.co.uk

+441252 718719

Study Officials

• Frances L Nicklin, Bsc, MCOptom

  Visioncare Research Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: August 14, 2017
• Primary Completion: November 17, 2017
• Study Completion: December 20, 2017
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2021-03

Locations

GB (6); US (5)