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

Not Applicable

Completed

• Conditions: Myopia; Hyperopia
• Interventions: Device: Test solution; Device: Control solution

• Registration Number: NCT03278223
• Lead Sponsor: OTE North America

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.

Study Timeline

• Study Start: 2017-08-14
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Primary Completion: 2017-11-17
• Study Completion: 2017-12-20
• Results First Submitted: 2019-08-30
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Results First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test solution	Test solution	A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
Control solution	Control solution	A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.

Primary Outcome Measures

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

Trial Locations

Locations (11)

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Frazier Vision, Inc.; 🇺🇸 Tyler, Texas, United States

Optometry Group PLLC; 🇺🇸 Memphis, Tennessee, United States

Leightons and Tempany; 🇬🇧 Poole, Bournemouth, United Kingdom

Eyesite; 🇬🇧 Reading, Berkshire, United Kingdom

Brock and Houlford; 🇬🇧 Chew Magna, Bristol, United Kingdom

First Contact; 🇬🇧 Eastcote, Pinner, United Kingdom

Golden Vision; 🇺🇸 Sarasota, Florida, United States

Visioncare Research Ltd; 🇬🇧 Farnham, Surrey, United Kingdom

Harrold Opticians; 🇬🇧 Uxbridge, Middlesex, United Kingdom