Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: omafilcon A

Device: somofilcon A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03226353

EX-MKTG-84

Details and patient eligibility

About

The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

Investigator responses to refit questions;
Lens fit.

Full description

This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Enrollment

77 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Exclusion criteria

Is participating in any concurrent clinical research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Contact Lens Research;
Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.