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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384628
• Other study ID #: TRTN-501
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: May 24, 2018

Study information

• Verified date: April 2018
• Source: Visioncare Research Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• First pair Senofilcon A contact lens
Fit assessment of the first pair contact lenses.
• Second pair Senofilcon A contact lens
Fit assessment of the second pair of contact lenses.
• Third pair Senofilcon A contact lens
Fit assessment of the third pair of contact lenses.

Locations

Country	Name	City	State
United Kingdom	Aston University Optometry Clinic	Birmingham	West Midlands
United Kingdom	Visioncare research	Farnham	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Graeme Young	Visioncare Research Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lens edge tightness fit grade 0-4	Edge tightness (grade 0-4)	5 minutes
Primary	Lens tightness fit graded as %	Tightness (push-up %),	5 minutes
Primary	Lens overall fit grade 0-5	Overall fit acceptability (Grade 0-5),	5 minutes