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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT04492397
• Lead Sponsor: Coopervision, Inc.

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 Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-09-30
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2021-05-27
• Results First Submitted QC: 2021-05-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Results First Posted: 2021-06-21
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Overall Lens Fit Acceptance	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 Outcome Measures

Name	Time	Method
Lens Centration	1 week	Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive \& occasionally encroaching limbus")
Post-blink Movement	1 week	Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Push-up Tightness	1 week	Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada