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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT03384628
• Lead Sponsor: Graeme Young

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-27
• Study Start: 2018-01-26
• Status Verified: 2018-04
• Primary Completion: 2018-05-24
• Study Completion: 2018-05-24
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lens fit (position on the eye) in mm	25 minutes	Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm),
Lens edge tightness fit grade 0-4	5 minutes	Edge tightness (grade 0-4)
Lens tightness fit graded as %	5 minutes	Tightness (push-up %),
Lens overall fit grade 0-5	5 minutes	Overall fit acceptability (Grade 0-5),

Trial Locations

Locations (2)

Visioncare research; 🇬🇧 Farnham, Surrey, United Kingdom

Aston University Optometry Clinic; 🇬🇧 Birmingham, West Midlands, United Kingdom