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

Graeme Young

Status: Completed

Conditions: Myopia

Treatments: Device: First pair Senofilcon A contact lens; Device: Second pair Senofilcon A contact lens; Device: Third pair Senofilcon A contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT03384628

TRTN-501

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 51 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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51 participants in 3 patient groups

First Pair Senofilcon A contact lens

Active Comparator group

Description:

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.

Treatment:

Device: First pair Senofilcon A contact lens

Second pair Senofilcon A contact lens

Active Comparator group

Description:

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.

Treatment:

Device: Second pair Senofilcon A contact lens

Third pair Senofilcon A contact lens

Active Comparator group

Description:

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.

Treatment:

Device: Third pair Senofilcon A contact lens