Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Overall Lens Fit Acceptance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 contact lenses in daily wear, for minimum of 6-months;
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- •Has an astigmatism of ≤ 1.00 D in subjective refraction;
- •Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- •Demonstrates an acceptable fit with the study lenses;
- •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
- •Is participating in any concurrent clinical or 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 because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is an employee of the Centre for Ocular Research & Education;
- •Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
- •Has participated in any clinical trials within a week prior to the study.
Arms & Interventions
Test Contact lens
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
Intervention: Test Contact Lens (Device)
Test Contact lens
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
Intervention: Control Contact Lens (Device)
Control Contact Lens
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
Intervention: Test Contact Lens (Device)
Control Contact Lens
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
Intervention: Control Contact Lens (Device)
Outcomes
Primary Outcomes
Overall Lens Fit Acceptance
Time Frame: 1 week
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Secondary Outcomes
- Lens Centration(1 week)
- Post-blink Movement(1 week)
- Push-up Tightness(1 week)
- Lens Centration(Baseline)
- Post-blink Movement(Baseline)
- Push-up Tightness(Baseline)