Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

NCT ID: NCT02588573

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

Brief Summary

The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Detailed Description

This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Conditions

Myopia

Study Design

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

Study Groups

Etafilcon A (control)

Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.

Group Type: ACTIVE_COMPARATOR

etafilcon A (control)

Intervention Type: DEVICE

contact lens

somofilcon A (test)

Intervention Type: DEVICE

contact lens

Somofilcon A (test)

Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.

Group Type: ACTIVE_COMPARATOR

etafilcon A (control)

Intervention Type: DEVICE

contact lens

somofilcon A (test)

Intervention Type: DEVICE

contact lens

Interventions

etafilcon A (control)

contact lens

Intervention Type: DEVICE

somofilcon A (test)

contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A person is eligible for inclusion in the study if he/she:

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

5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);

6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;

7. Demonstrates an acceptable fit with the study lenses;

8. Is usually able to wear contact lenses for at least 8 hours per day.

Exclusion Criteria

• A person will be excluded from the study if he/she:

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 substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;

6. Is aphakic;

7. Has undergone refractive error surgery.

8. Has participated in the previous somfofilcon A study (ORE# 20893)

• For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

• 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, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Contact Lens Research

Locations

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

University of Waterloo

Waterloo, , Canada

Countries

Canada

Other Identifiers

EX-MKTG-61

Identifier Type: -

Identifier Source: org_study_id