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

NCT ID: NCT03226353

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-06
• Study Completion Date: 2017-09-27

Brief Summary

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.

Detailed 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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

somofilcon A 1-day soft contact lenses

Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week

Group Type: EXPERIMENTAL

somofilcon A

Intervention Type: DEVICE

contact lens

omafilcon A

Intervention Type: DEVICE

contact lens

Interventions

somofilcon A

contact lens

Intervention Type: DEVICE

omafilcon A

contact lens

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-84

Identifier Type: -

Identifier Source: org_study_id