An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-26

Study Completion Date

2018-05-24

Brief Summary

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This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.

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Detailed Description

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This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).

Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each subject will wear the three contact lens types bilaterally in random succession

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects will be masked to lens type and lens codes. A sealed decoding envelope will be provided to the investigator. In the event of an emergency the investigator will break the masking and the medical monitor will be notified.

Study Groups

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First Pair Senofilcon A contact lens

The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal.

Group Type ACTIVE_COMPARATOR

First pair Senofilcon A contact lens

Intervention Type DEVICE

Fit assessment of the first pair contact lenses.

Second pair Senofilcon A contact lens

The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal.

Group Type ACTIVE_COMPARATOR

Second pair Senofilcon A contact lens

Intervention Type DEVICE

Fit assessment of the second pair of contact lenses.

Third pair Senofilcon A contact lens

The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal.

Group Type ACTIVE_COMPARATOR

Third pair Senofilcon A contact lens

Intervention Type DEVICE

Fit assessment of the third pair of contact lenses.

Interventions

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First pair Senofilcon A contact lens

Fit assessment of the first pair contact lenses.

Intervention Type DEVICE

Second pair Senofilcon A contact lens

Fit assessment of the second pair of contact lenses.

Intervention Type DEVICE

Third pair Senofilcon A contact lens

Fit assessment of the third pair of contact lenses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18-70 years.
* Able to read, comprehend and sign an informed consent.
* Willing to comply with the wear and study assessment schedule.
* Spherical distance prescription between -0.50 and -6.00 (inc.).
* Astigmatism, if present,≤1.50DC in both eyes.
* Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:

A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).

Exclusion Criteria

* Previous anterior ocular surgery
* Any active corneal infection, injury or inflammation

. •Large pinguecula likely to affect soft lens fit
* Systemic or ocular disease or medication which might interfere with CL wear
* Pregnancy or breastfeeding
* Participation in any concurrent trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes