Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

NCT ID: NCT04195893

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-24
• Study Completion Date: 2020-03-11

Brief Summary

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

Detailed Description

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

somofilcon A

Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.

Group Type: EXPERIMENTAL

somofilcon A

Intervention Type: DEVICE

Contact Lens

etafilcon A

Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

Contact Lens

Interventions

somofilcon A

Contact Lens

Intervention Type: DEVICE

etafilcon A

Contact Lens

Intervention Type: DEVICE

Other Intervention Names

Clariti 1-Day; 1-Day Acuvue Moist

Eligibility Criteria

Inclusion Criteria

• Subjects will only be eligible for the study if:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;

5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;

6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;

7. Demonstrates an acceptable fit with the study lenses;

8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria

• Subjects will not be eligible to take part in the study if:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Is an employee of the Centre for Ocular Research & Education;

10. Has participated in the BEAGLE (EX-MKTG-104) study.

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

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-112

Identifier Type: -

Identifier Source: org_study_id