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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Test Contact Lens; Device: Control Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT04492397

EX-MKTG-114

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Test Contact lens

Experimental group

Description:

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

Treatment:

Device: Control Contact Lens

Device: Test Contact Lens

Control Contact Lens

Active Comparator group

Description:

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

Treatment:

Device: Control Contact Lens

Device: Test Contact Lens