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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278223
• Other study ID #: OTES-3301
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2021
• Source: OTE North America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 20, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Brock and Houlford	Chew Magna	Bristol
United Kingdom	First Contact	Eastcote	Pinner
United Kingdom	Visioncare Research Ltd	Farnham	Surrey
United Kingdom	Leightons and Tempany	Poole	Bournemouth
United Kingdom	Eyesite	Reading	Berkshire
United Kingdom	Harrold Opticians	Uxbridge	Middlesex
United States	Optometry Group PLLC	Memphis	Tennessee
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Golden Vision	Sarasota	Florida
United States	Frazier Vision, Inc.	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
OTE North America	Visioncare Research Ltd.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	Limbal Hyperemia	Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)	Up to 4 weeks
Primary	Bulbar Hyperemia	Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)	Up to 4 weeks