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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: First pair Senofilcon A contact lens; Device: Second pair Senofilcon A contact lens; Device: Third pair Senofilcon A contact lens

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Farnham, Surrey, United Kingdom, GU9 7EN
      • Visioncare research
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 7ET
      • Aston University Optometry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: First pair Senofilcon A contact lens; Fit assessment of the first pair contact lenses.
Active Comparator: 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.	Device: Second pair Senofilcon A contact lens; Fit assessment of the second pair of contact lenses.
Active Comparator: 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.	Device: Third pair Senofilcon A contact lens; Fit assessment of the third pair of contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens fit (position on the eye) in mm	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),	25 minutes
Lens edge tightness fit grade 0-4	Edge tightness (grade 0-4)	5 minutes
Lens tightness fit graded as %	Tightness (push-up %),	5 minutes
Lens overall fit grade 0-5	Overall fit acceptability (Grade 0-5),	5 minutes

Collaborators and Investigators

• Sponsor: Graeme Young
• Collaborators: Visioncare Research Ltd.
• Investigators: Study Director: Graeme Young, PhD MPhil, Managing director

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): May 24, 2018
• Study Completion (Actual): May 24, 2018

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Contact lens; The Young Theory
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Refractive Errors; Seizures; Myopia
• Other Study ID Numbers: TRTN-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No