Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

NCT ID: NCT04492397

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-03-31

Brief Summary

The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

Detailed Description

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

Conditions

Myopia

Study Design

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

Study Groups

Test Contact lens

Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.

Group Type: EXPERIMENTAL

Test Contact Lens

Intervention Type: DEVICE

Subjects will be randomized to wear test lenses.

Control Contact Lens

Intervention Type: DEVICE

Subjects will be randomized to wear control lenses.

Control Contact Lens

Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.

Group Type: ACTIVE_COMPARATOR

Test Contact Lens

Intervention Type: DEVICE

Subjects will be randomized to wear test lenses.

Control Contact Lens

Intervention Type: DEVICE

Subjects will be randomized to wear control lenses.

Interventions

Test Contact Lens

Subjects will be randomized to wear test lenses.

Intervention Type: DEVICE

Control Contact Lens

Subjects will be randomized to wear control lenses.

Intervention Type: DEVICE

Other Intervention Names

stenfilcon A; verofilcon A

Eligibility Criteria

Inclusion Criteria

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 soft contact lenses in daily wear, 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. Has an astigmatism of ≤ 1.00 D in subjective refraction;

7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;

8. Demonstrates an acceptable fit with the study lenses;

9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria

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 because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;

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 BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;

11. Has participated in any clinical trials within a week prior to the 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, PhD FCOptom

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-114

Identifier Type: -

Identifier Source: org_study_id