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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2017-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test solution

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

Group Type ACTIVE_COMPARATOR

Test solution

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Control solution

Intervention Type DEVICE

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

Interventions

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Test solution

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

Intervention Type DEVICE

Control solution

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes